k040627, depuy orthopaedic, asr modular ace tabular cup system

510K SUMMARY - 5 pages 1

AMENDMENT - 5 pages 6

CORRESPONDENCE - 34 pages 11

ORIGINAL - 246 pages 45

REVIEWER INFORMATION - 100 pages 291

SUPPLEMENT - 129 pages 391

K0qc6;fl %,e r~

AUG 5 - 2005 5 10(k) Summary

NAME OF FIRM: DePuy Orthopaedics, Inc. PO Box 988 700 Orthopaedics Warsaw, IN 46581-0988

510(k) CONTACT: Natalie Heck Manager, Regulatory Affairs

TRADE NAME: DePuy ASR~m Modular Acetabular Cup System

COMMON NAME: Femoral Hip Prosthesis

CLASSIFICATION: Class mI per 21 CFR 888.3330 Hfip Joint metal/metal senilconstrained, with an unceinented acetahular component prosthesis

DEVICE PRODUCT CODE: 87 KWA

SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Pinnacle® Metal-on-Metal Acetabular Cup

Line (K002883 & K003523) Wright Medical Metal TRANSCEND®Articulation System (K02 1349) De~uy Ultima® Unipolar Head and Adapter Sleeves (K965 156)

DEVICE DESCRIPTION:

The DePuy ASRTm Modular Acetabular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral bead, and a taper sleeve adapter.

The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat® porous coating and is available in outer diameter sizes 44mm through 62mm in two-millimeter increments. The outer surface of the cup has a porous coating with the addition of a hydroxyapatite (H-A) coating. There are no separate liner components to this system, as the liners are integral to the one-piece acetabular cups.

The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is available in a range of diameters from 39 to 55 mm in two-millimeter increments. The uni femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy 12/14 or 11/13 tapers. The femoral heads articulate with corresponding one-piece metal acetabular cups.

The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters were previously cleared in the Ultima® Unipolar Head and Adapter

3

kONO6AY ( Cj 2 JC2)

Sleeves 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and

+12.

INDICATIONS FOR USE:

M in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip

joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

The DePuy ASR T Modular Acetabular Cup System is indicated for use

BASIS OF SUBSTANTIAL EQUIVALENCE:

DePuy believes the DePuy ASRTM Modular Acetabular Cup System to be substantially equivalent to the DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners; the Wright Medical Metal TRANSCEND Articulation System; and the DePuy Ultima Adapter Sleeves based upon the similarities in design, material composition, and intended use/indications for use.

4

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration 9200 Corporate Boulevard

AUG 5 - 2005 Rockville MD 20850

Ms. Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive PO Box 988 Warsaw, Indiana 46581-0988

Re: K040627 Trade/Device Name: DePuy ASRTM Modular Acetabular Cup System Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented

acetabular component, prosthesis Regulatory Class: Ill Product Code: KWA Dated: May 23, 2005 Received: May 24, 2005

Dear Ms. Heck:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Ms. Natalie Heck

This letter will allow you to begin marketing your device as described in your Section 510(k)

premarket notification. The FDA finding of substantial equivalence of your device to a legally

marketed predicate device results in a classification for your device and thus, permits your device

to proceed to the market. I .. . .. . ,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please

contact the Office of Compliance at (240) 276-0210. Also, please note the regulation entitled,

"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain

other general information on your responsibilities under the Act from the Division of Small orManufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041

(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh-industry/support/index.html.

Sincerely yours,

ar Melkerson Acting Director Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

5 10(k) Number (if known): Tt 0 Device Name: DePuy ASR Modular Acetabular Cup System

Indications for Use:

The DePuy ASR Tm Modular Acetabular Cup System is indicated for use in iotathip replacement in the hipprocedures for patients suffering severe pain and disability due to structural damage

joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders,

avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for

patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to

previous fusion, where bone stock is inadequate for other reconstruction techniques.

Prescription Use A /O Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(PostedNovember 13, 2003)

(Division Sign-Ofll) Division of General, Restorative, and Neurological Devices

510(k) Number 0 0612

*De~uy

Traditional N510(k)

Submission

K040627

DePuy ASRTM Modular Acetabular Cup System

Request for Additional Information July 29, 2005

IN a4si1ogaa700 ORTI4CPAEDIC DRIVE WARSAW

*DePuy 510(k): Premarket Notification

UcPu 1 Orthopaedics, Inc. Q0 i0" ~1~July 29, 2005 700 @nitopacdic Dave WNrssiW.. nd1,ara 46581-0988Food and Drug Administration

CDRLH/ODE Tei: 4-1(.574) 267 8143Document Mail Center (HFZ-4OI)

9200 Corporate Blvd. Rockville, MD 20850

Attn: Ms. Elizabeth Frank

Re: Additional Information - K040627 De~ly ASRTMModular Acetabular Cup System

Dear Ms. Frank:

DePuy Orthopaedics, Inc. submits the enclosed documentation in duplicate as an addendum to the

DePuy ASR TM Modular Acetabular Cup System, K040627, currently under review by FDA. This

submission is made as an update to information submitted on May 23, 2005 in response to a

request for additional information made by FDA letter request on January 26, 2005.

Based upon discussion with you on July 29, 2005 by telephone, DePuy is requesting that the

product codes for sizes 57, 59, 61, and 63mm diameters be withdrawn from this submission, and

have been removed from the Subject Device listing and the Summary Statement. An updated

product code listing and revised Summary Statement for the subject devices are included in this

additional information.

our intent to market this device and thisPursuant to 21 CFR 807.95(c) (3), DePuy considers

510(k) submission to be confidential commercial information and requests that FDA treats it as

De~uy has taken precautions to protect the confidentiality of the intent to market thesesuch. We understand that the submission to the government of false information is prohibiteddevices.

by 18 U.S.C. 1001 and 21 U.S.C. 331(q).

DePuy Orthopaedics acknowledges that the introduction of this device into domestic commercial

distribution will be contingent upon written clearance of the 510(k) by the Food and Drug

Administration.

Thank you in advance for your consideration of our application. If there are any farther questions

regarding this submission, please feel free to contact me via phone (574) 372-7469, fax (574)

371-4987, or email at nheck &ddus ini com.

Regards,

Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc.

2

510(k) Summary


Natalie Heck510(k) CONTACT: Manager, Regulatory Affairs

TRADE NAME: mDePuy ASRT Modular Acetabular Cup System

Femoral Hip ProsthesisCOMMON NAME:

Class I per 21 CFR 8883330 Hip JointCLASSIFICATION: metal/metal semiconstrained, with an uncemented acetabular component prosthesis

87 KWADEVICE PRODUCT CODE:

SUBSTANTIALLY DePuy Pinnacle® Metal-on-Metal Acetabular Cup

EQUIVALENT DEVICES: Line (K002883 & K003523) Wright Medical Metal TRANSCEND®Articulation System (K021349) DePuy Ultima® Unipolar Head and Adapter Sleeves (K965156)

DEVICE DESCRIPTION:

mThe DePuy ASRT Modular Acetabular Cup System is comprised of a one-piece metal acetabular

cup, a unipolar femoral head, and a taper sleeve adapter.

The acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-

piece cup with Porocoat® porous coating and is available in outer diameter sizes 44mm through The outer surface of the cup has a porous coating with the

62mm in two-millimeter increments. are no separate liner components to this

addition of a hydroxyapatite (HA) coating. There system, as the liners are integral to the one-piece acetabular cups.

The uni femoral head is manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is mm in two-millimeter increments. The uni

available in a range of diameters from 39 to 55

femoral heads have an internal taper which mates with a taper sleeve adapter specific to DePuy

The femoral heads articulate with corresponding one-piece metal12/14 or 11/13 tapers. acetabular cups.

The taper sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The

The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5.

11/13 taper sleeve adapters were previously cleared in the Ultima® Unipolar Head and Adapter

3

Sleeves 510(k), K(965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and

+12.


The .DePuy ASRC"m Modular Acetabular Cup System is indicated for use in total hip replacement

procedures for patients suffering severe pain and disability due to structural damage in the hip disorders,

joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen





De~uy believes the DePuy ASRTh Modular Acetabular Cup System to be substantially the WrightPinnacle Metal-on-Metal Acetabular Cup Linens;equivalent to the DePuy

Medical Metal TRANSCEND Articulation System; and the DePuy Ultima Adapter Sleeves

based upon the similarities in design, material composition, and intended use/indications for

use.

4i

De~uy ASRIm Modular Acetabular System - Revised 07/29/2005

Sizing catalog PartDescritin Number Number

39m 38.5 OD 999800139 999890239HeaUni Fmora Siz

-- 999800141 -9998902-4140.5 00Uni Femoral Head Size 41mm 9980~0143 9T99890-243Un FmoalHed iz 4mm425 0

44.5 0099015D9804Uni Femoral Head Size 45mm 0D 999800146 -9-99890246Headize 46mm45.5

- -- 999800147 99890247 -- TniW~emral

Uni Eemoral Hea Size 47mma 46.5 00 48.5 00 999800149 999890249Uni Femoral HedSize 49mm 50.50OD 999800151 999890251Uni Femoral Head Size 51Imm 52.5 On -- 9998001 53 9499890253Uni Femoral Had Size 53mm

54.490OD -- 999800155 -~999890255Uni Femoral Head Size 55mm 44 00 x 38.6 ID -999803944 99804Acetabular Shell size 44mm

46-mm 460 06 D99804146 999800746A-,c~etabular Shell-size 48 OD x 42.60 ID 99804348 999800748Acetabular Shell size 48mm 50 OD x 44.60 ID 999804550 §999800750Acetabular Shell size 50mm 52 00 x 45.60 ID 998452 999800752Acetabular Shell size 52mm 54 0D x 46.60 ID -4999804754 99805Acetabular Shell size 54mm 56 00 x 48.60 ID -- 999804956 99005Acetabular Shell size 56mm 5800D x 50.60 ID -9-99805158 ~ 4999800758Acetabular Shell size 58mm 60 00 x 52.60 ID -§999805360 999800760Acetabular Shell size 60mm 62 00 x 54.60 ID 9985562 999800762Acetblr Ihlsize 62mm

+2mm neck Ing, 12/14 taper 999800102 999800312Taper Sleeve Adapters 12/14 +2 Taper Sleeve Adap~ters 12/14~+5 ~+5num nec-ng,k 12/14 ~taper -999 80 0105 ~ S9998003 15

Taper Sleeve ~Adapters ~12/14 +8~+8m~mneckI~ng, 12/14 taper -- 999800108 999800318

5'


April 28, 2009 Food and Drug Administration Rockville MD 20857

DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. WARSAW INDIANA 46581

Re; Premarket Notification Number: K040627

Dear Manufacturer:

The Food and Drug Administration (FDA) is currently in the process of evaluating the classification of class III devices that are currently marketed through clearance of a premarket notification (510(k)) submission. These devices were found to be substantially equivalent to a preamendments class III device type for which no date has yet been established for requiring the submission of a premarket approval application (PMA). (A class III preamendments device type is a device type that was legally on the market before May 28, 1976, and that was subsequently classified into class III.) FDA premarket notification (510(k)) records indicate that you received clearance to market a device belonging to one of the class III device types being evaluated. Accordingly, FDA is requesting that you submit specific information, discussed below, to support these classification efforts. These classification efforts will culminate in a decision either to call for a PMA for these class III devices, or to reclassify these devices into Class II (special controls) or Class I (general controls). FDA will reach this decision based on all available and reviewed information pertaining to each device type. For certain device types, classification panel hearings may be held to assist in these efforts. Any future proposed decisions will apply to the device type as a whole, not solely to your individual device.

As stated, FDA, in accordance with Section 515(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. § 360e(i)), is requiring manufacturers who were marketing, or have clearance to market through a 5 10(k) substantial equivalence decision, the class III device types referenced above as of April 9, 2009, to submit certain information. The enclosed Federal Register notice details the specific device types, the requested information, and the submission instructions. You are required to submit this information by August 7, 2009, to:

Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD, 20852.

Please note that items posted to this docket will be redacted in accordance with the Freedom of Information Act (FOIA) (5 U.S.C. § 552), and posted to the docket. To ensure your posted documents are redacted, prior to posting, please denote submissions uploaded to the docket as such by typing the following words in the top of the "General Comments" box: "CONFIDENTIAL MA TERIAL DO NOT POST TO THE WEB AS REQUESTED BY SUBMITTER. STATUS SHOULD BE CONFIDENTIAL."

If you have information showing that you have received this letter in error, or that our records supporting this letter are inaccurate, such that you are relieved ofthe obligation to submit the requested information, please send an explanation of the error, noting your 510(k) number, to:

Attn.: 510(k) Staff, 515(i) Submission Document Mail Center, HFZ401 Center for Devices and Radiological Health 9200 Corporate Boulevard Rockville, MD, 20850

Please note that in lieu of submitting the above requested information, you may also petition FDA to reclassify the device type in accordance with Section 513(e) of the act (21 U.S.C. 360c(e)) and our regulations found in 21 CFR Part 860. In general, FDA's review of reclassification petitions can be completed more efficiently when manufacturers collaborate and submit a single reclassification petition that includes all relevant and accurate information for the given device type. This collaboration can be organized by contacting other manufacturers of the pertinent device through either a professional association or other affiliation.

Additional information or inquiries relevant to this classification mandate can be obtained by referencing the FDA Class m website at: http://www.fda.gov/cdrh/classiii.html. or bY contacting Sarah K. Morabito at (240) 276-3975.

Sincerely yours,

Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and

Radiological Health Enclosure

Public Health ServiceDEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard

AUG 5 2005 Rockville MD 20850 -

Ms. Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc.

700 Orthopaedic Drive PO Box 988 Warsaw, Indiana 46581-0988

Re: K040627 DePuy ASRTM Modular Acetabular Cup SystemTrade/Device Name:

Regulation Number: 21 CFR 888.3330

Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented

acetabular component, prosthesis

Regulatory Class: III Product Code: KWA Dated: May 23, 2005 Received: May 24, 2005

Dear Ms. Heck:

We have reviewed your Section 510(k) premarket notification of intent to market the device

referenced above and have determined the device is substantially equivalent (for the indications

for use stated in the enclosure) to legally marketed predicate devices marketed in interstate

commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to

devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,

and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). The

You may, therefore, market the device, subject to the general controls provisions of the Act.

general controls provisions of the Act include requirements for annual registration, listing of

devices, good manufacturing practice, labeling, and prohibitions against misbranding and

adulteration.

If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA), it

may be subject to such additional controls. Existing major regulations affecting your device can In addition, FDA may

be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. Register.publish further announcements concerning your device in the Federal

Please be advised that FDA's issuance of a substantial equivalence determination does not mean

that FDA has made a determination that your device complies with other requirements of the Act

or any Federal statutes and regulations administered by other Federal agencies. You must

comply with all the Act's requirements, including, but not limited to: registration and listing (21

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic

product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Ms. Natalie Heck

This letter will allow you to begin marketing your device as described in your Section 510(k)

The FDA finding of substantial equivalence of your device to a legallypremarket notification. marketed predicate device results in a classification for your device and thus, permits your device

I-to proceed to the market. , - ,

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please Also, please note the regulation entitled,

contact the Office of Compliance at (240) 276-0210. You may obtain

"Misbranding by reference to premarket notification" (21CFR Part 807.97).

other general information on your responsibilities under the Act from the Division of Small or

Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 htnfi.

(301) 443-6597 or at its Internet addresshttp:/wwwfov/cdrtr//suport/index

Sincerely yours,

Mark . Melkerson Acting Director Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

Indications for Use

510(k) Number (if known): _h 4 C 2.7DePuy ASRTM Modular Acetabular Cup SystemDevice Name:


The DePuy ASR TM Modular Acetabular Cup System is indicated for use in totaLhip replacement

pain and disability due to structural damage in the hipsevereprocedures for patients suffering

joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders,




Over-The-Counter Use Prescription Use _~.

(21 CFR 807 Subpart C)(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF

NEEDED)


PageI of 1


(Division Sgn-O Division of General, Restorative,

and Neurological Devices

510(k) Number t<0 ~(0 3 4

DEPARTMENT OF HEALTH AND HUA SERVICESPulcHatSeve

Food and Drug Administration Centet for Devices and . Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9Z00 Corporate Blvd.

March07, 2005 ~~~~~~~Rockville, Maryland 20850

DEPUY ORTHOPAEDICS, INC. 510(k) Number: K040627 700 ORTHOPAEDIC DR. Product:DEUAS P.O. BOX 988 MODULAR WARSAW, IN 46581 AEAUA U ATTN: NATALIE HECK SYSTEM

Extended Until: 25-MAY-2005

Based on your recent request, an extension of time has been granted for you to submit the additional information we requested.

If the additional information is not received by the "Extended Until" date shown above your premarket notification will be considered withdrawn.

if you have procedural or policy questions, please contact the Division of Small Manufacturers International and Consumer Assistance (DSMICA) at (301) 443-6597 or at their toll-free number (800) 638-2041, or contact me at (301) 594-1190.

Sincerely yours,

Marjorie Shulman Supervisory Consumer Safety Officer Premarket Notification Section Office of Device Evaluation Center for Devices and Radiological Health

HIl

*DePuy a company

DePuy Orthopaedics, Inc.

P0 Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581 -0988 USA

March 4, 2005 Tel: ±1 (574) 267 8143

Ms. Beth Frank Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, MD 20850

Re: K(040627, Request for 90-Day Extension, Deputy ASR- Modular Acetabular Cup

System

Dear Ms. Frank:

DePuy would like to request a 90-day extension to respond to the request for additional information dated January26, 2005, regarding K040627, ASR-h Modular Acetabular Cup System. The information requested requires additional time to complete.

Please contact me directly at 574-372-7469, or nheck 'tny~ushnL••!m, if you have any questions or need any additional information regarding this request.

Sincerely,

Natalie'S. Heck Manager, Regulatory Affairs

CD

(b) (4)

(b) (4)

DEPARTMENT OF HEALTH &HUMAN SERVICES Public Health Service

Food and Drug Administration9200 Corporate BoulevardRockville MD 20850

Ms. Natalie HeckManager, Regulatory Affairs JAN 2 6 2005DePuy Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, Indiana 4658 1-0988

Re: K040627/SITrade Name: DePuy ASRT m Modular Acetabular Cup SystemDated: December 2, 2004Received: December 3, 2004

Dear Ms. Heck:

We have reviewed your Section 5 1 0(k) premnarket notification of intent to market the

device referenced above. We cannot determine if the device is substantially equivalent to alegally marketed predicate device because you did not adequately respond to the

deficiencies listed in our June 3, 2004 letter. To complete the review of your submission,

we require you address the following issues:

1 . The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System iscomposed of Cast High Carbon Co-Cr-Mo alloy (ASTM F-75), with diametrical

clearances of and sizes ranging from 39-63mm. Your predicate

Pinnacle TM Metal-on-Metal Acetabular Cup (K003523, K002883) is composed of

Wrought Co-Cr-Mo alloy (ASTM F-1537), with diametrical clearances between

and diameters of 28 or 36mm.

a. In Supplement 1, you referenced a previously submitted

11/3

(b) (4)

(b) (4) (b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

Page 2 - Ms. Natalie Heck

b. provided in Supplement 1 range from

c. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System has

Based on our concerns regarding the , we believe clinical data are necessary to support a new metal-on-

metal system. If the clinical data are collected in the US, the clinical data would

need to be collected as part of a FDA-approved investigational device exemption(IDE) application. We recommend that you contact us prior to submission of an

IDE to address any questions related to the clinical study design.

2. Several of the provided test reports were performed using devices,

and these results are being used to support the articulation of the large diameterunipolar femoral heads and ASR acetabular cups in the subject submission. In

, ." While

the , hip systems are evaluated as an entireassembly. Differences between the

will affect the loading of the system, as well as wear patterns. We do not believethat preclinical testing of a can be appropriately substituted as

preclinical testing for a total hip system. Therefore the following reports submitted in

Supplement 1 are not considered to be applicable to this submission and the originaldeficiencies referencing these reports remain:

(b) (4)

(b) (4)

(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4) (b) (4)

(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)

(b) (4) (b) (4)

(b) (4)

(b) (4)(b) (4)


*fn addition, please recognize that the used in this test report is

currently

3. In response to Question 5, you have submitted

components of this system. As described above, we do

not believe preclinical testing of

comparable results, due to differences in in vivo loading conditions. Therefore, the

original deficiency remains and both

. In addition, the provided testing for

the acetabular cup does not address our concerns regarding

.

4. The proposed acetabular component is a cobalt-chrome molybdenum (CoCrMo) alloy

one-piece cup with Porocoat® porous coating with the addition of DuoFix

hydroxyapatite (HA) coating on the outer surface. Your previously cleared Pinnacle

metal-on-metal (MOM) acetabular cup is designed as a wrought CoCrMo superfinished

metal liner that assembles into a porous coated, titanium alloy metal shell. We have

:

a. l

b.

The deficiencies identified above represent the issues that we believe need to be resolved

before our review of your 510(k) submission can be successfully completed. In developing

the deficiencies, we carefully considered the statutory criteria as defined in Section 513(i)

of the Federal Food, Drug, and Cosmetic Act for determining substantial equivalence of

your device.

//5-

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)(b) (4)

Ms. Natalie Heck

We also considered the burden that may be incurred in your attempt to respond to the

We believe that we have considered the least burdensome approach todeficiencies. resolving these issues. If, however, you believe that information is being requested that is

not relevant to the regulatory decision or that there is a less burdensome way to resolve the

issues, you should follow the procedures outlined in the "A Suggested Approach to

Resolving Least Burdensome Issues" document. It is available on our Center web page at:

~~~~~~~~~udnoehr

You may not market this device until you have provided adequate information described

above and required by 21 CFR 807.87(l), and you have received a letter from FDA

If you market the device without conforming to these requirements,allowing you to do so. You may,you will be in violation of the Federal Food, Drug, and Cosmetic Act (Act).

however, distribute this device for investigational purposes to obtain clinical data if needed

to establish substantial equivalence. Clinical investigations of this device must be

conducted in accordance with the investigational device exemption (IDE) regulations.

If the information, or a request for an extension of time, is not received within 30 days, we

will consider your premarket notification to be withdrawn and your submission will be

deleted from our system. If you submit the requested information after 30 days it will be

considered and processed as a new 510O(k); therefore, all information previously submitted Please note our guidancemust be resubmitted so that your new 5 10(k) is complete.

document entitled, "Guidance for Industry and FDA Staff FDA and Industry Actions on

Premarket Notification (510O(k)) Submissions: Effect on FDA Review Clock and

Performance Assessment". The purpose of this document is to assist agency staff and the

device industry in understanding how various FDA and industry actions that may be taken

on 510(k)s should affect the review clock for purposes of meeting the Medical Device User

Fee and Modernization Act. You may review this document at

ha~p /~/wwwfda gov/cdrhb/mdutfi auidance/ 121M9htmll.

The requested information, or a request for an extension of time, should reference your

above 5 10(k) number and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and

Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

Ms. Natalie Heck

If you have any questions concerning the contents of the letter, please contact Ms.

Elizabeth Frank at (301) 594-1307, extension 115. If you need information or assistance

concerning the IDE regulations, please contact the Division of Small Manufacturers, or at (301)International and Consumer Assistance at its toll-free number (800) 638-2041

443-6597, or at its Internet address http://www.fda.gov/cdrh/indupex.html.

Sincerely yours,A

j

I Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative


Radiological Health

(b) (4)

(b) (4)

Ms. Natalie HeckManager, Regulatory AffairsDePuy Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, Indiana 46581-0988

Re: K040627/S1Trade Name: DePuy ASR"" Modular Acetabular Cup SystemDated: December 2, 2004Received: December 3, 2004

Dear Ms. Heck:

We have reviewed your Section 510(k) premarket notification of intent to market thedevice referenced above. We cannot determine if the device is substantially equivalent to alegally marketed predicate device because you did not adequately respond to thedeficiencies listed in our June 3, 2004 letter. To complete the review of your submission,

we require you address the following issues:

1. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System iscomposed of Cast High Carbon Co-Cr-Mo alloy (ASTM F-75), with diametricalclearances of and sizes ranging from 39-63mm. Your predicatePinnacleT MMetal-on-Metal Acetabular Cup (K003523, K002883) is composed of

Wrought Co-Cr-Mo alloy (ASTM F-1537), with diametrical clearances between and diameters of 28 or 36mm.

hip

:

a. In Supplement 1, you referenced a previously submitted "

(b) (4)

(b) (4) (b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)


b. The diametrical clearances and tolerances provided in Supplement 1 range from


Based on our concerns regarding the , we believe clinical data are necessary to support a new metal-on-

metal system. If the clinical data are collected in the US, the clinical data would

need to be collected as part of a FDA-approved investigational device exemption

(IDE) application. We recommend that you contact us prior to submission of an


2. Several of the provided test reports were performed using ,

and these results are being used to support the articulation of the large diameterunipolar femoral heads and ASR acetabular cups in the subject submission. In

that preclinical testing of a can be appropriately substituted aspreclinical testing for a total hip system. Therefore the following reports submitted in

Supplement 1 are not considered to be applicable to this submission and the original

deficiencies referencing these reports remain:

/10

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)(b) (4)


*In addition, please recognize that the used in this test report is

3.In response to Question 5, you have submitted

data on the of this system. As described above, we do

not believe preclinical testing of provide

comparable results, due to differences ini~ivo loading conditions. Therefore, the

original deficiency remains and both

system is na.ee~. In addition, the provided testing for

the acetabular cup does not address our concerns regarding

.

4. The proposed acetabular component is a cobalt-chrome molybdenum (CoCrMo) alloy

one-piece cup with Porocoat® porous coating with the addition of DuoFix

hydroxyapatite (HA) coating on the outer surface. Your previously cleared Pinnacle

metal-on-metal (MOM) acetabular cup is designed as a wrought CoCrMo superfinished

metal liner that assembles into a porous coated, titanium alloy metal shell. We have

:

a.

b.

.

The deficiencies identified above represent the issues that we believe need to be resolved

before our review of your 5 10(k) submission can be successfully completed. In developing

the deficiencies, we carefully considered the statutory criteria as defined in Section 513(i)

of the Federal Food, Drug, and Cosmetic Act for determining substantial equivalence of

your device.

Ik)

(b) (4)

(b) (4)

(b) (4)(

b) (4)

(b) (4)

(b) (4)

(b) (4)(b) (4)

Ms. Natalie Heck

We also considered the burden that may be incurred in your attempt to respond to the deficiencies. We believe that we have considered the least burdensome approach to resolving these issues. If, however, you believe that information is being requested that is not relevant to the regulatory decision or that there is a less burdensome way to resolve the issues, you should follow the procedures outlined in the "A Suggested Approach to Resolving Least Burdensome Issues" document. It is available on our Center web page at:

http://www.fdajzov/cdrh/modact/leastburdensome.html

You may not market this device until you have provided adequate information described above and required by 21 CFR 807.87(1), and you have received a letter from FDA allowing you to do so. If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug, and Cosmetic Act (Act). You may, however, distribute this device for investigational purposes to obtain clinical data if needed

to establish substantial equivalence. Clinical investigations of this device must be conducted in accordance with the investigational device exemption (IDE) regulations.

If the information, or a request for an extension of time, isnot received within 30 days, we will consider your premarket notification to be withdrawn and your submission will be deleted from our system. If you submit the requested information after 30 days it will be considered and processed as a new 510(k); therefore, all information previously submitted must be resubmitted so that your new 51 0(k) is complete. Please note our guidance document entitled, "Guidance for Industry and FDA Staff FDA and Industry Actions on

Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment". The purpose of this document is to assist agency staff and the

device industry in understanding how various FDA and industry actions that may be taken on 51 0(k)s should affect the review clock for purposes of meeting the Medical Device User Fee and Modernization Act. You may review this document at http://www.fda. gov/cdrh/mdufma/guidance/1219.html.

The requested information, or a request for an extension of time, should reference your above 510(k) number and should be submitted in duplicate to:


Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

ut:rA1IMENT OF HEALTH AND HUMAN SERVICES


If you have any questions concerning the contents of the letter, please contact Ms. Elizabeth Frank at (301) 594-1307, extension 115. If you need information or assistance

concerning the IDE regulations, please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301)

443-6597, or at its Internet address http://www.fda. gov/cdrh/industr,//support/index.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative


Radiological Health

__.c _Omc ___0~l` _ _INRUE . ~..... J........ .........

,~,,~~-- -- ....................................

Ms. Natalie Heck

cc: HFZ-401 DMC HFZ-404 5 10(k) Staff HFZ-410 Division D.O.

f/t:Efrank:tmj :1-25-05

(2?3

Public Health ServiceDEPARTMENT OF HEALTh AND HUMAN SERVICES

Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (ffFZ-401) 9200 Corporate Blvd.

Rockville, Maryland 20850September 01, 2004

DEPUY ORTHOPAEDICS, INC. 510(k) Number: K040627

700 ORTHOPAEDIC DR. Product: DEPUY ASR MODULARP.O. BOX 988 ACETABULAR CUPWARSAW, IN 46581

ATTN: NATALIE HECK SYSTEM

Extended Until: 03-DEC-2004

Based on your recent request, an extension of time has been granted

for you to submit the additional information we requested.

If the additional information is not received by the "Extended Until"

date shown above your premarket notification will be considered

withdrawn.

If you have procedural or policy questions, please contact the

Division of Small Manufacturers International and Consumer Assistance

(DSMICA) at (301) 443-6597 or at their toll-free number (800) 638-2041,

or contact me at (301) 594-1190.

Sincerely yours,

Marjorie Shulman Supervisory Consumer Safety Officer

Premarket Notification Section Office of Device Evaluation Center for Devices and

Radiological Health

*DePuy DePuy Orthopaedics, Inc.

PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 USA Tel: +1(574) 267-8143

Aug 31, 2004

Ms. Beth Frank Food and Drug Administration Center for Devices and Radiological Health

Office of Device Evaluation Document Mail Center (HFZ-401)

9200 Corporate Blvd.

Rockville, MD 20850

Re: K040627, Request for 90-Day Extension, DePuy ASR- Modular Acetabular Cup

System

Dear Ms. Frank:

DePuy would like to request an additional 90-day extension to respond to the request for Modular Acetabular

additional information dated June 3, 2003, regarding K040627, ASR-

Cup System. The testing information requested requires additional time to complete.

Please contact me directly at 574-372-7469, or nheck aLdpyus.ini.com if you have any

questions or need any additional information regarding this request.

Sincerely,

- aManager, Regulatory AffairsManagerS. Heck

Public Health ServiceDEPARTMENT OF HEALTH AND HUMAN SERVICES


Radiological Health

Office of Device Evaluation

Document Mail Center (HFZ-401) 9200 Corporate Blvd.

Rockville, Maryland 20850July 30, 2004

510(k) Number: K040627DEPUY ORTHOPAEDICS, INC. Product: DEPUY ASR700 ORTHOPAEDIC DR.

MODULARP.O. BOX 988 ACETABULAR CUPWARSAW, IN 46581 SYSTEMATTN: NATALIE HECK

Extended Until: 03-SEP-2004




date shown above your premarket notification will be considered

withdrawn.

If you have procedural or policy questions, please contact the and Consumer AssistanceDivision of Small Manufacturers International

443-6597 at their toll-free number (800) 638-2041,(DSMICA) at (301) or


Sincerely yours,


Premarket Notification Section Office of Device Evaluation Center for Devices and

Radiological Health

Q3 c

*DePjy +~ti 4 tn+etnof company


P0 Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581 -0988 USA Tel: ±1 (574) 267 8143July 29, 2004

Ms. Beth Frank Food and Drug Administrationm Center for Devices and Radiological Health. office of Device Evaluation Document Mail Center (HFZ-401I) 9200 corporate Blvd.

Rockville, MD 20850

Re: 1K040627, Request for 30-Day Extension, De~uy ASR- Modular Acetabulaieiup ~

T0aSystem

Dear Ms. Frank:

DePuy would like to request a 30-day extension to respond to the request for additional Modular Acetabular Cupinformation dated June 3, 2003, regarding K040627, ASR-

System. The testing information requested requires additional time to complete.

Please contact me directly at 574-372-7469, or nheckgidvvusini.cmm if you have any

questions or need any additional information regarding this request.

Sincerely,

Manager, Regulatory Affairs

7



Radiological Health



Rockville, Maryland 20850July 06, 2004

DEPUY ORTHOPAEDICS, INC. 510(k) Number: K040627

700 ORTHOPAEDIC DR. Product: DEPUY ASR MODULARP.O. BOX 988 ACETABULAR CUPWARSAW, IN 46581 SYSTEMATTN: NATALIE HECK

Extended Until: 03-AUG-2004




date shown above your premarket notification will be considered withdrawn.



(DSMICA) at (301) 443-6597 or at their toll-free number (800) 638-2041,


Sincerely yours,


ODeFuy DePuy Orthopaedics, Inc.

PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 USA

July I, 2004US Tel: +1 (574) 267 8143

Ms. Beth Frank Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-40 1) 9200 Corporate Blvd. Rockville, MD 20850

Re: K040627, Request for 30-Day Extension, DePuy ASR TMModular Acetabular Cup System

Dear Ms. Frank:

DePuy would like to request a 30-day extension to respond to the request for additional information dated June 3, 2003, regarding K040627, ASR"" Modular Acetabular Cup System. The information requested requires additional time to research and to assemble, as we need to coordinate with our colleagues in Leeds.

Please contact me directly at 574-372-7469, or nheck(a~dpyus.ini.com if you have any questions or need any additional information regarding this request.

Sincerely,

Na ieS.ek1 Manager, Regulatory Affairs

CD

CD

Qc43

Public Health ServiceDEPARTMENT OF HEALTH &HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc. P0 Box 988 700 Orthopaedic Drive

Warsaw, Indiana 4658 1-0988 'JUN 0 3 2004

Re: K040627 Trade Name: DePuy ASRTMModular Acetabular Cup System

Dated: March 8, 2004 Received: March 9, 2004

Dear Ms. Heck:

We have reviewed your Section 510(k) premarket notification of intent to market the device

We cannot determine if the device is substantially equivalent to a legallyreferenced above. marketed predicate device based solely on the information you provided. To complete the

review of your submission, we require that you address the following items:

The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composedI.

of Cast High Carbon Co-Cr-Mo alloy (ASTM F-75), while your predicate Pinnacler"M

Metal-on-Metal Acetabular Cup (K003523 & K002883) is composed of Wrought Co-

The change in material alters the articulating surfaces ofCr-Mo alloy (ASTMFE-1537). your system creating new safety concerns. Although the Wright Medical

TRANSCEND®~ Articulation System (K021349) is composed of Cast Co-Cr-Mo alloy

(ASTM F-75), this system had its own clearances and tolerances, which were proven to

be safe and effective through their own clinical data. Your diametrical clearances and

tolerances have not been identified in your submission.

In addition, you have proposed 39-63mmn inner diameters for your acetabular cups with

matching femoral head diameters. Your Pinnacle predicate only exists in 28 and 36 mm It is unknown what effectsizes and the Wright TRANSCEND® Systemn is 38-54mm.

While weincreasing the diameter to 63fimn will have on the clinical use of the system.

have allowed several small increases in diameters with appropriate bench top testing, we

are unsure how large is actually safe for clinical use.

All of these design differences can significantly influence the clinical outcomes for

These changes present safety concerns that wemetal-on-metal hip arthroplasty devices.

(b) (4)

(b) (4)(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)

(b) (4)

Page 2 - Natalie Heck

feel cannot be addressed by preclinical testing and must be addressed by clinical data tosupport a determination of substantial equivalence of your 5 10(k). If the clinical dataare collected in the US, the clinical data would need to be collected as part of a FDA-approved investigational device exemption (IDE) application. We recommend that youcontact us prior to submission of an IDE to address any questions related to the clinicalstudy design.

2. The test reports submitted in Exhibit 4 refer to a that is currentlyunder an IDE study with the FDA Please clarify which components of thissystem are identical to the components in the IDE study and which areunique to this submission. Please complete approriate on theworst-case scenario for the components in this submission or

e

3. The submission states, "The modularity of using taper sleeve adapters in two taperoptions allow for a reduced number of fernoral head components while o ffering variousfernoral head offsets and compatibility with multiple fernoral stems." The size of thefemoral head can affect the fatigue strength of the femoral stem in vivo. Therefore, we

the system. Please provide an . Please justify your choice for the worst case

head/stem construct (e.g., head with largest lateral offset, stem most likely to fail infatigue).

4. The subject heads use taper sleeve adapters to mate the femoral head to the fernoralstem. The taper sleeve adapter results in a somewhat hollow head design which may besusceptible to additional failure modes (i.e. fatigue fracture involving the cylindricalshaft in which the Sleeve Adapter fits) that a solid head would not encounter. Webelieve , to assess the strength of the cylindrical sleeve adapter shaft, isnecessary to establish the safety and effectiveness of the device. Please provide an

5. The test reports included in Exhibit 4 address In addition to

(b) (4)(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)

(b) (4) (b) (4)

(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)


component . Therefore, we believe

the an important parameter in assessing thesafety and effectiveness of a metal-on-metal hip system. Please provide

on the system both before and

after the devices

The deficiencies identified above represent the issues that we believe need to be resolvedbefore our review of your 510(k) submission can be successfully completed. In developing

the deficiencies, we carefully considered the statutory criteria as defined in Section 513(i) of

the Federal Food, Drug, and Cosmetic Act for determining substantial equivalence of yourdevice. We also considered the burden that may be incurred in your attempt to respond to the

deficiencies. We believe that we have considered the least burdensome approach to resolving

these issues. If, however, you believe that information is being requested that is not relevant

to the regulatory decision or that there is a less burdensome way to resolve the issues, youshould follow the procedures outlined in the "A Suggested Approach to Resolving LeastBurdensome Issues" document. It is available on our Center web page at:http://www.fda.gov/cdrh/modact/leastburdensome.html

You may not market this device until you have provided adequate information describedabove and required by 21 CFR 807.87(1), and you have received a letter from FDA allowing

you to do so. If you market the device without conforming to these requirements, you will be

in violation of the Federal Food, Drug, and Cosmetic Act (Act). You may, however,distribute this device for investigational purposes to obtain clinical data if needed to establish

substantial equivalence. Clinical investigations of this device must be conducted in

accordance with the investigational device exemption (IDE) regulations.

If the information, or a request for an extension of time, is not received within 30 days, we

will consider your premarket notification to be withdrawn and your submission will be deleted

from our system. If you submit the requested information after 30 days it will be considered

and processed as a new 510(k); therefore, all information previously submitted must beresubmitted so that your new 510(k) is complete.

The requested information, or a request for an extension of time, should reference your above

5 10(k) number and should be submitted in duplicate to:

Food and Drug AdministrationCenter for Devices andRadiological Health

Document Mail Center (HFZ-401)9200 Corporate BoulevardRockville, Maryland 20850

Natalie Heck

If you have any questions concerning the contents of the letter, please contact Elizabeth Frank

at (301) 594-1307, extension 115. If you need information or assistance concerning the IDE

regulations, please contact the Division of Small Manufacturers, International and Consumer

or at (301) 443-6597, or at its InternetAssistance at its toll-free number (800) 638-2041 address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

C a Celia M. Witten, Ph.D., M.. Director Division of General, Restorative


Radiological Health

Natalie HeckManager, Regulatory AffairsDePuy Orthopaedics, Inc.PO Box 988700 Orthopaedic DriveWarsaw, Indiana 46581-0988 JUl 0 O 2004

Re: K040627Trade Name: DePuy ASRTm Modular Acetabular Cup SystemDated: March 8, 2004Received: March 9, 2004

Dear Ms. Heck:

We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above. We cannot determine if the device is substantially equivalent to a legallymarketed predicate device based solely on the information you provided. To complete thereview of your submission, we require that you address the following items:

1. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composedof Cast High Carbon Co-Cr-Mo alloy (ASTM F-75), while your predicate Pinnacle TM

Metal-on-Metal Acetabular Cup (K003523 & K002883) is composed of Wrought Co-Cr-Mo alloy (ASTM F-1537). your system creating new safety concerns. Although the Wright MedicalTRANSCEND® Articulation System (K021349) is composed of Cast Co-Cr-Mo alloy(ASTM F-75), this system had its own clearances and tolerances, which were proven tobe safe and effective through their own clinical data. Your diametrical clearances andtolerances have not been identified in your submission.

In addition, you have proposed 39-63mm inner diameters for your acetabular cups withmatching femoral head diameters. Your Pinnacle predicate only exists in 28 and 36 mmsizes and the Wright TRANSCEND® System is 38-54mm. It is unknown what effectincreasing the diameter to 63mm will have on the clinical use of the system. While wehave allowed several small increases in diameters with appropriate bench top testing, weare unsure how large is actually safe for clinical use.

All of these design differences can significantly influence the clinical outcomes formetal-on-metal hip arthroplasty devices. These changes present safety concerns that we

(b) (4)

(b) (4)

(b) (4)(b) (4)

(b) (4)(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)


feel cannot be addressed by preclinical testing and must be addressed by clinical data tosupport a determination of substantial equivalence of your 510(k). If the clinical dataare collected in the US, the clinical data would need to be collected as part of a FDA-approved investigational device exemption (IDE) application. We recommend that youcontact us prior to submission of an IDE to address any questions related to the clinicalstudy design.

2. The test reports submitted in Exhibit 4 refer to a that is currentlyunder an IDE study with the FDA Please clarify which components of thissystem are identical to the components in the IDE study and which areunique to this submission. Please complete approriate on theworst-case scenario for the components in this submission or

3. The submission states, "The modularity of using taper sleeve adapters in two taperoptions allow for a reduced number of femoral head components while offering variousfemoral head offsets and compatibility with multiple femoral stems." The size of thefemoral head can affect the fatigue strength of the femoral stem in vivo. Therefore, webelieve

.

4. The subject heads use taper sleeve adapters to mate the femoral head to the femoralstem. The taper sleeve adapter results in a somewhat hollow head design which may besusceptible to additional failure modes (i.e. fatigue fracture involving the cylindricalshaft in which the Sleeve Adapter fits) that a solid head would not encounter. Webelieve , to assess the strength of the cylindrical sleeve adapter shaft, isnecessary to establish the safety and effectiveness of the device. Please provide an

5. The test reports included in Exhibit 4 address In addition to have been known to cause

.),45

(b) (4)(b

) (4)

(b) (4)

(b) (4)(b) (4)(b) (4)

(b) (4)

(b) (4)

(b) (4) (b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)(b) (4)


component Therefore, we believe is an important parameter in assessing the

safety and effectiveness of a metal-on-metal hip system. Please provide , data on the system both before and

after the devices .

The deficiencies identified above represent the issues that we believe need to be resolvedbefore our review of your 5 10(k) submission can be successfully completed. In developingthe deficiencies, we carefully considered the statutory criteria as defined in Section 5 13(i) ofthe Federal Food, Drug, and Cosmetic Act for determining substantial equivalence of yourdevice. We also considered the burden that may be incurred in your afttempt to respond to thedeficiencies. We believe that we have considered the least burdensome approach to resolvingthese issues. If, however, you believe that information is being requested that is not relevantto the regulatory decision or that there is a less burdensome way to resolve the issues, youshould follow the procedures outlined in the "A Suggested Approach to Resolving LeastBurdensome Issues" document. It is available on our Center web page at:http ://www.fda.gov/cdrh/modact/leastburdensome html

You may not market this device until you have provided adequate information describedabove and required by 21 CFR 807.87(l), and you have received a letter from FDA allowingyou to do so. If you market the device without conforming to these requirements, you will bein violation of the Federal Food, Drug, and Cosmetic Act (Act). You may, however,distribute this device for investigational purposes to obtain clinical data if needed to establishsubstantial equivalence. Clinical investigations of this device must be conducted inaccordance with the investigational device exemption (IDE) regulations.

If the information, or a request for an extension of time, is not received within 30 days, wewill consider your premarket notification to be withdrawn and your submission will be deletedfrom our system. If you submit the requested information after 30 days it will be consideredand processed as a new 5 10(k); therefore, all information previously submitted must beresubmitted so that your new 5 10(k) is complete.

The requested information, or a request for an extension of time, should reference your above5 10(k) number and should be submitted in duplicate to:

Food and Drug AdministrationCenter for Devices and

Radiological HealthDocument Mail Center (HFZ-401)9200 Corporate BoulevardRockville, Maryland 20850

______________

DEPARTMENT OF HEALTH AND HUMAN SERVICES


If you have any questions concerning the contents of the letter, please contact Elizabeth Frank

at (301) 594-1307, extension 115. If you need information or assistance concerning the IDE

regulations, please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative


Radiological Health

IIIU\S'I'1 IIY itt1I

\IIT~~~~~~~~~~~~~~~~~~~~t1SOR.1114!StIRNAMIIFU \41cV

Natalie Heck

cc: HFZ-401 DMC HFZ-404 510(k) Staff HFZ- 410 Division D.O.

f/t:EFrank:elh:5/27/04


Food and Drug Administration

Center for Devices and Radiological Health

Office of Device Evaluation Document Mail Center (HFZ-401)


March 09, 2004 Rockville, Maryland 20850

DEPUY ORTHOPAEDICS, INC. 510(k) Number: K040627 09-MAR-2004700 ORTHOPAEDIC DR. Received:

Product: DEPUY ASR MODULAR ACETABULAR CUP

P.O. BOX 988 WARSAW, IN 46581 ATTN: NATALIE HECK SYSTEM

The Food and Drug Administration (FDA), Center for Devices and Radiological

Health (CDRH), has received the Premarket Notification you submitted in and Cosmetic Actaccordance with Section 510(k) of the Federal Food, Drug,

(Act) for the above referenced product. We have assigned your submission a

unique 510(k) number that is cited above. Please refer prominently to this

510(k) number in any future correspondence that relates to this submission.

We will notify you when the processing of your premarket notification has been

completed or if any additional information is required. YOU MAY NOT PLACE

THIS DEVICE INTO COMMERCIAL DISTRIBUTION UNTIL YOU RECEIVE A LETTER FROM FDA

ALLOWING YOU TO DO SO.

The Act, as amended by the Medical Device User Fee and Modernization Act of 2002 collect user fees for premarket(MDUFMA)(Public Law 107-250), authorizes FDA to

notification submissions. (For more information on MDUFMA, you may refer to our

website at http://www.fda.gov/oc/mdufma).

Please remember that all correspondence concerning your submission MUST be

sent to the Document Mail Center (DMC)(HFZ-401) at the above letterhead address.

Correspondence sent to any address other than the above will not be consideredone

as part of your official premarket notification submission. Also, please note

the new Blue Book Memorandum regarding Fax and E-mail Policy entitled,

"Fax and E-Mail Communication with Industry about Premarket Files Under Review".

Please refer to this guidance for information on current fax and e-mail

practices at www.fda.gov/cdrh/ode/a02-Ol.html.

You should be familiar with the manual entitled, "Premarket Notification 510(k)

Regulatory Requirements for Medical Devices" available from DSMICA. If you

have other procedural or policy questions, or want information on how to check

on the status of your submission, please contact DSMICA at (301) 443-6597 or

its toll-free number (800) 638-2041, or at their Internet address

http://www.fda.gov/cdrh/dsmamain.html or me at (301)594-1190.

Sincerely yours,

Marjorie Shulman Supervisory Consumer Safety Officer Office of Device Evaluation Center for Devices and Radiological Health

Medical Device User Fee Cover Sheet - FDA Form 3601 Page 1 ofI

Form Approved:OMB No 0910-0511 Expiration Date: Auust 31,200 OM Stem~ent

DEPARTMENT OF HEALTH AND HUMAN SERVICESILA

FOOD~ ~~~ ~~ANDDUYDIITAINMENT 0'12545 ~ iDENTIFICATION NUMBER: MEDICAL DEVICE USER FEE COVER SHEET rite the Payment Identification Number on your check.

n to properly submit your application and fee payment: A completed Cover Sheet must accompany each original application or supplement subject to fees. The following actions must betae

1. Electronically submit the completed Cover Sheet to the Food and Drug Administration (FDA) before payment is sent. 2. Include a printed copy of this completed Cover Sheet with a check made payable to the Food and Drug Administration. Remember

that the Payment Identification Number must be written on the check. 3. Mail Check and Cover Sheet to the US Bank Lock Box, FDA Account, P.O. Box 956733, St. Louis, MO 63195-6733. (Note: Inno

case should payment be submitted with the application.) 4. Ifyou prefer to send a check by a courier, the courier may deliver the check and Cover Sheet to: US Bank, Attn: Government

Lockbox 956733, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This address is for courier delivery only. Contact the US Bank at 314-4184821 ifyou have any questions concerning courier delivery.)

5. For Wire Transfer Payment Procedures, please refer to the MDUFMA Fee Payment Instructions at the following URL: htlp//www fda gov/cdrh/mdufma/faqs htrnl#3a. You are responsible for paying all fees associated with wire transfers.

6. Include a copy of the completed Cover Sheet involume one of the application when submitting to the FDA at either the CBER or CDRH Document Mail Center.

1. COMPANY NAME AND ADDRESS (Include name, street 2. CONTACT NAME address, city, state, country, and post office code) TIFFANY LYON

DEPUY JOHNSON &JOHNSON 2.1 E-MAIL ADDRESS 700 ORTHOPAEDIC DRIVE tlyon~dpyus.jnj.com WARSAW, IN46582

2.2 TELEPHONE NUMBER (Include Area Code) 574-371-4945

1.1 EMPLOYER IDENTIFICATION NUMBER (EIN) 352109957 2.3 FACSIMILE (FAX) NUMBER (Include Area Code) 1_

574-371-4987

3. TYPE OF PREMARKET APPLICATION (Select one of the following in each column; ifyou are unsure, please refer to the application descriptions at the following web site: http://www fda.gov/oc/mdufrna

of the types below:Select an application type: 3.1 Select one

Premarket notification (510(k)); except for third party reviews Original Application

E Biologics License Application (BLA) Supplement Types:

E Premarket Approval Application (PMA) [ Efficacy (BLA)

[ Modular PMA El Panel Track (PMA, PMR, PDP)

[] Product Development Protocol (PDP) H Real-Time (PMA, PMR, PDP)

El Premarket Report (PMR) H] 180-day (PMA, PMR, PDP)

4. ARE YOU A SMALL BUSINESS? (See the instructions for more information on determining this status.)

H] YES, Imeet the small business criteria and have submitted the ~:' NO, I am not a small business required qualifying documents to FDA

4.1 IfYes, please enter your Small Business Decision Number:

5. ISTHIS PREMARKET APPLICATION COVERED BY ANY OF THE FOLLOWING USER FEE EXCEPTIONS? IFSO, CHECK THE APPLICABLE EXCEPTION.

This application is the first PMA submitted by a qualified small H The sole purpose of the application isto support business, including any affiliates, parents, and partner firms conditions of use for a pediatric population

H] This biologics application is submitted under section 351 of the H] The application is submitted by a state or federal Public Health service Act for a product licensed for further government entity for adevice that is not to be distributed manufacturing use only commercially

6. IS THIS A SUPPLEMENT TO A PREMARKET APPLICATION FOR WHICH FEES WERE WAIVED DUE TO SOLE USE INA PEDIATRIC POPULATION THAT NOW PROPOSES CONDITION OF USE FOR ANY ADULT POPULATION? (Ifso, the application is subject to the fee that applies for an original premarket approval application (PMA).)

DYES 9NO

7. USER FEE PAYMENT AMOUNT SUBMITTED FOR THIS PREMARKET APPLICATION (FOR FISCAL YEAR 2004)

$3,480.00 Form FDA 3601 (08/2003)

https://fdasfinapp4.fda.gov/CFAPPS/mdufma/coversheet/Index.cfm?fuseactionWfuse RptCo.. 1/7/20

CDRH SUBMISSION COVER SHEET Date of Submission: FDA Document Number:

Section A Type of Submission

PMA PMA Supplement PDP 510(k) Meeting0 Pre-IDE mtng.

0 Regular U Presubmission Summary Original Submission: 0 Pre-PMA mtg. Original Submission U Special U Original PDP X Traditional D Pre-PDP ntg. O Modular U Panel Track El Notice of intent to start 0 Special C 180-Day mtg.

clinical trials n Abbreviated C other (specify'):Submission U 30-day Supplement o Amendment U 30-day Notice U Intention to submit n Additional o Report U 135-day Supplement Notice of Completion Information: El Report C Real-time Review 0 Notice of Completion C Traditional

Amendment 0 Amendment to PMA C Amendment to POP U Special Supplement C Report El Abbreviated

0 Report Amendment

IDE Humanitarian Device Class II Exemption Evaluation of Other Submission

Exemption Automatic Class III U original submission U Original submission 0 Original Submission Designation Describe El Amendment 0 Amendment U Additional Information Submission: o Supplement U Supplement U Original Submission

o Report U Additional Information

Section B Applicant or Sponsor

Company/Institution Name: Establishment registration number.1818910 DEPUY, INC.

Division Name (if applicable): NA Phone number (include area code): (574) 371-4905

Street Address: 700 Orthopatedic Drive Fax number (include area code): (574) 371-4987

City: State/Province: Zip code: Country: United States of AmericaWarsaw IN 46582

Contact Name: Natalie Heck

Contact Title: Manager, Regulatory Attain Contact e-mail address: nheck~dpyus~jnj.com

Section C Submission Correspondent (if different from above)

Company/Institution Name: Establishment registration number:

Division name (if applicable) Phone number (include area code):

Street Address: Fax number (include area code):

City: State/Province: Zi oe: Country

Contact Name.

Section Di Reason for Submission - PMAPDP, or HDE

C New Device CChange in design, component, or specification: C Location Change: O Withdrawal C Software C Manufacturer o Additional or Expanded Indications U Color Additive C Sterilizer o Licensing Agreement C Material C Packager

o Specifications C Distributor 0oOther (specify below)

o Processing Change: C Manufacturing C Labeling Change: CReport Submission: C Sterilization El Indications CAnnual or Periodic C Packaging C instructions El Post Approval Study El Other (specify below) C Perfonmance Characteristics 0 Adverse Reaction

C Shelf Life C1 Device Defect o Response to FDA correspondence: C Trade Name C Amendment

C3 Request for applicant hold Cl other (specify below)_ C Request for removal of applicant hold C Request for extension C Change inOwnership C1 Request to remove or add manufacturing site CChange in correspondent

C Other Reason (specify):

Section D2 Reason for Submission - IDE

Cl New device Change in: C Response to FDA letter concerning: C Addition of institution n Correspondent C Conditional approval C Expansion/extension of study C Design 0 Deemed approval Cl IRB certification C Informed consent C Deficient final report C Request hearing C Manufacturer C Deficient progress report C Request waiver C Manufacturing process 0 Deficient investigator report Cl Termination of study 0 Protocol - feasibility C Disapproval C] Withdrawal of application El Protocol - other Cl Request extension for time to o Unanticipated adverse effect CSponsor respond to FDA C Notification of emergency use Cl Request meeting o Compassionate use request Cl Report Submission: C Treatment IDE Dturrent investigator C Continuing availability request C Annual progress

C Site waiver limit reached C Final

C Other reason (specify):

Section D3 Reason for Submission - 510(k)

X New Device C Change in technology Cl Change inmaterials o Additional or expanded indications XChange in design 03 Change inmanufacturing processoOther reason (specify):

Section E Additional Information on 510(k) Submissions

Product codes of devices to which substantial equivalence is claimed: Summary of, or statement concerning safety and effectiveness data:

KWAK WA WA 3 KWL X 510(k) summary attached

6 80510(k) statement

Manufacturer510(k) Number Trade of Proprietary or model name

I DePuyI K002883 I Pinnacle Metal-on-Metal Acetabular Cup Line

2 Wright Medical2 K021349 2 Transcend Femoral Heads

3 DePuy3 K965156 3 Ultima Unipolar Head and Adapter Sleeves

44 4

55 5

66 6

Section F Product Information - Applicable to All Applications

Common or usual name or classification name: Hip Prosthesis

Model NumberTrade or proprietary or model name

I DePuy ASR Modular Acetabular Cup System I 9998001391999800163; 999803944/999806370; 9Q9RAifil 0/7O9RAAil OR

22

33

44

55

FDA document numbers of all prior related submissions (regardless of outcome):

NONE 2 3 4 5 6

8 9 t0 1 1 12

Data included in submission: X Laboratory Testing [ Animal Trials [ Human Trials

Section G Product Classification - Applicable to All Applicants

'roduct code: 87KWA ] C.F.R. Section 888.3320 & 888.3330 Device Class:

Panel: Orthopedic Devices Branch, Division ofGeneral and Restorative Devices I c Class I [ Class IIClassification X Class III Unclassified(D GR D).

Indications (from labeling): Unchanged from K002883, see attached

I~~A

(b) (4)

(b) (4) (b) (4)

(b) (4)

(b) (4) (b) (4)

(b) (4)

(b) (4)

(b) (4)

Note: Submission of this infonnation does not affect the need to submit a 2891 or 2891 IaFDA Document Number:Device Establishment Registration form.

Section H- ManufacturilglPackagiflg/Sterilizatiofl Sites Relating to a Submission

K Original FD salsmnt registration number: X Manufacturer Oaontract SterilizerEl Add U Deee810379 El Contract Manufacturer U Repackager/relabeler

Company/Institution name: DePuy International, Inc. Establishment registration number: 8010379

Division name (if applicable): Phone number (include area code): +44 (113) 270 0461

Street address: St. Anthony's Road FAX number (include area code): +44 (113) 270 4101

City Leeds State/Province NA Zip code: LSI SD onr nited Kingdom

Contact name: U.S. contact: Natalie Heck

Contact title: Manager, Regulatory Affairs

X Original FAEtbihetregistration number 0 auatrer X Contract Sterilizer

Ul Add elee rc Manufacturer 0 Repackager/relabeler

Company/Institution Name: FEstablishment registration number:

Division name (if applicable Phone number (include area code):

Street address: ): FAX number (include area code):

City: State/Province: NA Zip code: CutyU

Contact name:

Company/Institution name: Establishment registration number:

Division name (if applicable): Phone number (include area code):

Street address: FAX number (include area code):

City: State/Province: Zip code: Cuty

Contact name.

Contact title: Contact e-mail address:

(b) (4)

*De~uy

TRADITIONAL 510(k)

SUBMISSION


700 Orthopaedic Drive Warsaw, IN 46580

~Qt

*De~uy a com~~wpany


PO Box 988 510(k) Notification 700 Orthopaedic Drive

Indiana 46581 -0988~~~~~~~~~~~~~Warsaw,March8,2004 ~~~~~~~~~~USAMarch8, 2004

Tl 1(7)2784Food and Drug Administration CDRIVIODE Document Mail Center (HFZ-40 1)

9200 corporate Blvd. Rockville, MD 20850

SUBJECT: 510(k) Premnarket Notification Sse

DePuy ASRTM Modular Acetabular Cup Sse

Dear Sir/Madam:

Pursuant to 21 CFR § 807.81, please find submitted in duplicate the following.9remarket Modular

notification of the intent of DePuy Orthopaedics to introduce the DePuy ASR

Acetabular Cup System into commercial distribution. These products are reviewed by the

orthopedic Devices Branch in the Division of General and Restorative Devices (DGRD).

to be trade secret andinformation stamped "CONFIDENTIAL"We consider technical

confidential commercial information, not available for disclosure under 21 CFR Part 20.

device into domesticthat the introduction of thisDePuy Oirthopaedics acknowledges

commercial distribution will be contingent upon written clearance of the 510(k) by the Food and

Drug Administration. Substantial equivalence information provided in the document is for the

purpose of FDA marketing clearance only; it in no way reflects upon the patentability of the

device.

to contact me at If you have any questions regarding this submission, please do not hesitate

(574) 372-7469 Phone, (574) 371-4987 Fax, or email nheck( dpvtus.IflICOm.

Regards,

Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc.

MDePuy ASR T Modular Acetabular Cup System

Table of Contents Page

C ove r .............................Letter Table of Contents ........................................ ..................C rtfi aton.....,........................·.......,.....................,............Tthr ulan A cu acIndications for Use Statement....................

.... .o.....o.,-...,..........·.........................Tr uthfulA ccuracy Certification ....................................................

....

and 6in510(k) Su mmary ...................................

Premarket Notf i Cicat and Summary................................................ 8l ationClas.....Certification

B . C ontact on ..... *,......................................Per ......................Index for 510(knP rem.arket Notification

L Administrative Information A. MenufaeturerInformation..........................................................................

10..ntact ......................................................................................B. Co Person

D. Predicate Device Information .................................................................. 1. E. Indications f or d................................................................................... 1. C.DeviceDe fori ation.1F. Materials. ...................................................................................A. Device Description .....................................................................................

Drawings ................................................................................ 1

L. E n gineering ......................................................................................H. Proposed Labeing

H .DeviceDescription A. Dev Desc ........................................................... 2...17ice quption.1 B D b.evice Photographes(Figx ........................................... 13.

IIT. Compliance w ithSpecial Controls ................................................................ 1 IV. Sterilization & Packaging

14A. Sterilization ...................................................................................e B. Packaging Informaion.............................................................................. 1.

V. Labelingnd ertising ......................................................................a Adv R ...........................................................................VI. Testing S..1ory

VIi. Substantial Equivalence Eq Devices

Table 1: Similarities and Differences Matrix .18.................... Design/Materials of Construction Indications

Table 2: Predicate ..................................................... 1900

A. Substanti ally uivalent ......

Devices B. Basis for Substantial Equivalence .20...........................................................

EXHIBITS 1. List of Devices.20..................

...........................................232. Engineerng drawings ...................................353. Draft Product Label and Insert ......................................514. Test Reports

5. HA coating/substrate Manufacturing Information.....9...... 6. Predicate Device Information.200.........................

3

Indications for Use

510(k) Number (if known): MC&Ž,Device Name: DePuy ASR Modular Acetabular Cup System


The DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

Prescription Use ADO Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)


Page _ of


4

Truthful and Accuracy Certification

In accordance with 21 CFR §807.87 (j), I believe to the best of my knowledge, that all the data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.

Nataltieeck Date Manager, Regulatory Affairs

5

510(k) Summary


510(k) CONTACT: Natalie Heck Manager, Regulatory Affairs

TRADE NAME: DePuy ASRTM Modular Acet ular Cup System

COMMON NAME: Femoral Hip Prosthesis

CLASSIFICATION: Class III per 21 C FR8.3330 Hip Joint metal/metal semiconstrained, w an uncemented acetabular component prost sis

DEVICE PRODUCT CODE: 87 KWA

SUBSTANTIALLY EQUIVALENT DEVICES: DePu nnacle® Metal-on-Metal Acetabular Cup

Line 02883 & K003523) Wfght Medical Metal TRANSCEND Articulation

stem (K021349) ePuy Ultima® Unipolar Head and Adapter Sleeves

/(K965156)

DEVICE DESCRIPTION:

The DePuy ASRTM Modular Acet ular Cup System is comprised of a one-piece metal acetabular cup, a unipolar femoral head, ana taper sleeve adapter.

The acetabular component i designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat® rous coating and is available in outer diameter sizes 44mm through 70mm in two-millimeter crements. The outer surface of the cup has a porous coating with the addition of a hydroxyan atite (HA) coating. There are no separate liner components to this system, as the liners ar integral to the one-piece acetabular cups.

The uni femoral he rdis manufactured from cobalt-chrome molybdenum (CoCrMo) alloy and is

available in a ra ;e of diameters from 39 to 63 mm in two-millimeter increments. The uni femoral heads ye an internal taper which mates with a taper sleeve adapter specific to DePuy

12/14 or 11/ tapers. The femoral heads articulate with corresponding one-piece metal acetabular c s.

The tap sleeve adapters are manufactured from cobalt-chrome molybdenum (CoCrMo) alloy. The 114 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/1 taper sleeve adapters were previously cleared in the Ultima® Unipolar Head and Adapter Sleyevs 510(k), K965156 (Jan 24, 1997), and are offered in neck length options of +0, +6, and

+ 2.

2+4 6

5¢¢ At


entThe DePuy ASR TM Modular Acetabular Cup System is indicated for use in total hip replace pain and disability due to structural damage in the jointprocedures for patients suffering severe

from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, vascular

necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated ients with

congenital hip dysplasia, slipped capital femoral epiphysis and disability due to vious fusion,

where bone stock is inadequate for other reconstruction techniques.


DePuy believes the DePuy ASR M Modular Acetabular Cup System to e substantially equivalent to the DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners; e Wright Medical Metal

TRANSCEND Articulation System; and the DePuy Ultima Ad ter Sleeves based upon the

similarities in design, material composition, and intended use/indic ions for use.

7

March 8, 2004

PREMARKET NOTIFICATION CLASS HI CERTIFICATION AND SUMMARY

(As Required by 21 CFR 807.94)

I certify that, inmy capacity as Manager of Regulatory Affairs at DePuy Orthopaedics, Inc., aJohnson &

Johnson company, that I have conducted areasonable search of all information known or otherwise

available about the types and causes of safety or effectiveness problems that have been reported for

metal-on-metal total hip systems. I further certify that I am aware of the types of problems to which

metal-on-metal total hip systems are susceptible and that, to the best of my knowledge, the following

summary of the types and causes of safety or effectiveness problems iscomplete and accurate.

Natalie 6 4 ~Q

Date

(Premarket Notification [510(k)] Number)

DePuy ASR Modular Acetabular Cup System

SUMMARY OF THE TYPES AND CAUSES OF

SAFETY OR EFFECTIVENESS PROBLEMS

METAL-ON-METAL TOTAL HIP SYSTEMS

Based on the literature summary provided in G960262 for the DePuy Ultima Metal-On-

Metal Acetabular Cup System, the most significant complications associated with

historical metal-on-metal total hip replacement systems include:

Loosening, possibly related to surgical technique, poor fixation, sub-optimal bearing* design resulting in high frictional torque and/or bearing seizure, or sub-optimal range

of motion in early designs; * Pain, possibly related to loosening; * Calcar resorption, possibly related to poor early stem designs and not the metal-on

metal articulation;

Other potential complications, which could be associated with metal-on-metal hip

replacement, but have not been conclusively documented clinically include:

· Local and systemic reactions to increased metal ion release and metal wear debris,

especially a higher incidence of certain site specific cancers;

Fretting and corrosion of the implant due to galvanic corrosion between dissimilar* metals;

Other types of safety and effectiveness problems that are associated with metal-on-metal hip

replacement are those that are associated with all total joint replacements. These include:

infection, dislocation, cardiovascular disorders (including venous thrombosis, pulmonary

embolism, and myocardial infarction), pneumonia, atelectasis, hematoma, nerve damage,

delayed wound healing, reaction to bone cement, metal sensitivity, bone fracture, soft tissue

imbalance, failure to relieve pain, failure to restore range of motion and deformity of the

joint.

In order to reduce the chance of complications with a metal-on-metal hip replacement

device, the following conditions, which tend to adversely affect safety and/or

effectiveness of any total joint arthroplasty, should be reduced or eliminated: marked

osteoporosis with poor bone stock and danger of impaired abutment of implants, systemic

and metabolic disorders leading to progressive deterioration of solid bone support for the

implant (e.g. cortisone therapies, immunosuppressive therapies), history of general

infectious disease (e.g. erysipelas) or local infectious disease, severe deformities leading

to impaired anchorage or improper positioning of the implant, tumors of the supporting

bone structure, allergic reactions to the implant materials, and tissue reactions to

corrosion or wear products.

S

(b) (4)

TRADITIONAL 510(K)

DePuy ASR TM Modular Acetabular Cup System

ADMINISTRATIVE INFORMATION:

A. Manufacturer: DePuy International LimitedSt. Anthony RoadLeedsWest YorkshireUK LS II 8DT

EstablishmentRegistration Number: 8010379

Contract Sterilizer:

B. Contact Person: Natalie HeckManager, Regulatory AffairsTelephone (574) 372-7469Fax: (574) 3714939Email: nheck(aWdvvus~jni.com

C. Subject Device Information:

Proprietary Name: DePuy ASR TM Modular Acetabular Cup System

Total Hip ProsthesisCommon Name:

Class III per 21 CFR 888.3330 Hip JointRegulatory Class & Reference: metal/metal semiconstrained, with an uncemented

acetabular component prosthesis

Product Code & Name: 87 KWA Prosthesis, Hip, Femoral Metal/Metal

10

D. Predicate Device Information:

DePuy Pinnacle Metal-on-Metal K003523 Cleared December 13, 2000 Acetabular Cup Line K002883 Cleared October 13, 2000

Wright Medical Metal K021349 Cleared July l, 2002 TRANSCEND® Articulation System

DcPuy Ultirna Unipolar Head and K965156 Cleared January 24, 1997 Adapter Sleeves

Copies of the 510(k) clearance letters are provided in Exhibit 6.

E. Indications for Use:

The DePuy ASRTM Modular Acetabular Cup System is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

F. Materials:

Acetabular Cup: ASTM F-75 Cast High Carbon Cobalt Chromium Molybdenum Alloy

Femoral Head: ASTM F-75 Cast High Carbon Cobalt Chromium Molybdenum Alloy

Taper Sleeve ASTM F-799 Forged Cobalt Chromium Molybdenum Alloy Adapter:

G. Engineering Drawings:

Engineering drawings are provided in Exhibit 2.

H. Proposed Labeling:

Draft labels and the package insert can be found in Exhibit 3.

11]

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[I. DEVICE DESCRIPTION:

A. Device Description:

The acetabular component is designed as a cobalt-chrome molybdenum (Co r o) alloy one-piececup with PorocoatCR porous coating with the addition of a hydroxyapatite (HA) coating on the outersurface. The acetabular shell has a highly polished, superfinished internal bearing surface, and isavailable with outer diameter sizes 44mm through 70mm in two-millimeter increments. The shellcomponent uses the same Porocoat® process used for the predicate device (K002883 & K003523).There is no separate liner component to this system, as it is a one-piece acetabular shell used with aunipolar femoral head and a taper sleeve adapter.

Porocoat' porous coating has been fully characterized in previous PN4A and 5 10(k) submissions(e.g., P820024 AMIL, and K030979 Solution System).

Below is a summary of the properties of the Porocoat®; porous coating:

The outer surface of the cup has the addition of a hydroxyapatite (HA) coating.Characteristics of the HA coating on the CoCrMo Porocoat substrate are found in

(see contractor reference letter and DePuy raw material specification provided in Exhibit5). The HA material conforms to ASTM Ft 1185-88 for hydroxyapatite (Ca 5(P04)30H) ceramic.

The uni femoral head is manufactured from cast high carbon cobalt-chrome molybdenum (CoCrMo)alloy and is available in a range of diameters from 39 to 63mm in two-millimeter increments. All ofthe uni femoral heads have an internal taper which mates with a CoCrMo taper sleeve adapterspecific to the 12/14 or 11113 tapers corresponding to the external tapers on DePuy femoral stems.The femoral heads have a highly polished, superfinished exterior bearing surface, and articulate withcorresponding one-piece metal acetabular cups. (See representative device photographs).

The ASR 12/14 taper sleeve adapters are manufactured from forged cobalt-chrome molybdenum(CoCrMo) alloy. The 12/114 taper sleeve adapters are offered in neck length options of +1.5, +5, and+8.5.

The 11/ 13 taper sleeve adapters are manufactured from wrought CoCrMo alloy and were previouslycleared in the Ultima Unipolar Head and Sleeve 5 1 0(k), K965 156 (Jan 24, 1997), and are offered inneck length options of +0, +6, and + 12.

1 2

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B. Device Photonahs:

Fig 1: ASR One-piece Cup, sample Unipolar Femnoral Head & ASR Sleeve Adapter

/

Fig 2: Assembled Components Fig 3: Exploded Components Shown with S-ROM stem Shown with S-ROM stem

'3

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(b) (4)

(b) (4)(b) (4)

III. COM'IPIAAN(E WITH SPECIAL CONTROLS:

Sections 513 anti 514 of The Act, as amended under the Safe Medical Devices Act of 1990, do apply tothis type of device, but a performance standard has not yet been promulgated. Further, DePuy is notaware of any requirements for postmarket surveillance or other special controls for this device at thistime.

IV. STERILIZATION AND PACKAGING:

A. STERILIZATION METHOD:

The subject devices are supplied packaged and sterilized by exposure to

* The sterilization method has been validated by using

* * No claims are made regarding pyrogenicity.

B. PACKAGING INFO:

The package materials protecting sterility are

V. LABELING AND ADVERTISING:

The package insert and draft labels are provided in Exhibit 3.

VI. TESTING SUMMARY:

:

14

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(b) (4)(b) (4)

(b) (4)

DePuy Leeds Research Department Report RDR 151/03 is provided in Exhibit 4.

a.......................DI..IBBB.IIBBtB I l BI iiiB m.....Bi.B.iBi.B.i

DePuy Leeds Research Department Reports RDR 045/03, 143/02, 283/02, 284/02, 043/03, 128/03, and032/03 are provided in Exhibit 4.

15

(b) (4)

(b) (4)

(b) (4)

(b) (4)

DePuy Leeds Research Department Reports RDR 044/03, 307/02, 006/03, 299/02, 037/03, 145/03,141/03, 082/03 and 065/03 are provided in Exhibit 4.

16

(b) (4)(b) (4)

(b) (4)

Nil. SUBSTANTIAL EQUIVALENCE:

A. SUBSTANTIALLY EQUIVALENT DEVICES:

Acetabular Shell ComponentThe DePuy ASRTM Modular Acetabular Cup System acetabular component is designed as a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with Porocoat® porous coating and is available inouter diameter sizes 44mm through 70mm in two-millimeter increments. The outer surface of the cuphas a porous coating with the addition of a hydroxyapatite (HA) coating. There is no separate linercomponent to this system, as it is a one-piece acetabular shell used with a unipolar femoral head andtaper adapter sleeves.

The Pinnacle metal-on-metal (MOM) acetabular cup is designed as a wrought CoCrMo superfinishedmetal liner that assembles into a porous coated, titanium alloy metal shell. The Pinnacle MOM liner isavailable in 28 & 36mm inner diameter options, for use with corresponding 28 & 36mm CoCrMo metalfemoral heads.

The Wright Medical Metal TRANSCEND one-piece acetabular cup is a cast, high carbon CoCrMo alloy.The cup sizes range from 46 through 64mm and accept femoral heads from 36 through 54mm indiameter. The TRANSCEND acetabular cup has a superfinished inner diameter, with a porous coatedouter diameter.

The subject device shell component uses Porocoat® material and process that is used for previouslycleared devices (P820024 AML and K030979 Solution System).

The interior of the shell isdesigned to articulate with the subject uni femoral heads. Articulating surfaces of both the uni femoralhead and one-piece acetabular cup are superfinished to ensure form tolerance and a fine surface finish.The HA powder used in the plasma spray process, conforms to ASTM Fl 185-88 Hydroxyapatite(Ca5(PO4) 3OH) ceramic.

Femoral HeadsThe subject uni femoral heads are substantially equivalent to Wright Medical's TRANSCENDArticulation System. Both are supplied in larger diameter sizes (DePuy: available in 39mm through63mm; Wright: available in 38mm through 54mm). Both are manufactured from cast high carbonCoCrMo alloys conforming to ASTM specifications and articulate with a one-piece CoCrMo alloyacetabular shell. Articulating surfaces of both the uni femoral head and one-piece acetabular cup aresuper finished to ensure proper tolerances. DePuy heads are available in diameters up to63mm,

.

Taper Sleeve AdaptersThe subject heads use taper sleeve adapters to mate the femoral head to the femoral stem, whereas thePinnacle MOM and TRANDSCEND Articulation Systems use a range of femoral heads designed withspecific internal taper specifications to fit with femoral stem tapers. The modularity of using tapersleeve adapters in two taper options allow for a reduced number of femoral head components whileoffering various femoral head offsets and compatibility with multiple femoral stems. The subject devicetaper connections are manufactured from forged CoCrMo alloy and are based upon the design used forthe adapter sleeves described in the DePuy Ultima Unipolar Adapter Sleeves 510(k). K965156 clearedon Jan 24, 1997.

17

(b) (4)(b) (4)

Table 1: Similarities and Differences Matrix

Proposed DePuy ASR Uni Femnoral Head

and Acetabular Cup System

Design/Material:

Femoral Heads

Material Cast High Carbon Co-Cr-Mo alloy

(STr-M [F-75)

Diameters 39nim-63mm (in 2mm increments)

Articulation Superfinished surface Requirements

Taper Sleeve 12/14 external taper Adapters sleeve adapters

manufactured from Taper Geometry wrought CoCrMo alloy

(ASTM F-799)

Taper/ Neck Taper Sleeve Adapters: Lengths

12/14 taper: +1.5, +5, +8.5

l 1/13 taper: +0, +6, -12 (see Ultima taper

sleeve adapters)

Acetabular Low Profile Component One Piece Shell

Material Cast High Carbon Co-Cr-Mo alloy (ASTM F-75)

OD Coating Porocoat® Porous Coating with DuoFix TM

HA coating

Outer Diameter 44m-70mm (in 2mm increments)

Inner Diameter 39mm-63mm

Articulation Superfinished surface Requirements

DePuy PinnacleTM

Metal-on-Metal Acetabular Cup

K003523 & K002883

Wrought Co-Cr-Mo alloy (ASTM F-1537)

28mm & 36mm

Superfinished surface

Femoral Heads:

12/14 and 11/13 internal tapers

28mm Femoral Heads: 12/14 taper: +1.5, +5,

+8.5 11/13 taper: +0, +3, +6

36mm Femoral Heads: 12/14 taper: -2, +1.5,

+5, +8.5, +12 11/13 taper: +0, +3,

±6, +9, +12 Metal Liner

Wrought CoCrMo alloy

(ASTM F-1537)

N/A

48mm-66mm (in 2mm increments)

28mm & 36mm

Superfinished surface

Wright Medical DePuy Ultima Metal Unipolar Adapters

TRANSCENDI Articulation System K965156

K021349

Cast High Carbon N/A Co-Cr-Mo alloy

(ASTM F-75)

38mm-54mm N/A (in 2mm increments)

Superfinished surface N/A

Femoral Heads: I I/] 3 external taper 12/14 internal taper sleeve adapters Cast High Carbon manufactured from

CoCrMo alloy wought CoCrMo (ASTM F-75) alloy (ASTM F

1537)

Femoral Heads: Taper Sleeve

12/14 taper: -3.5, 0, +3.5 11/13 taper: +0, +6,

+12

Low Profile One Piece Shell

Cast High Carbon N/A Co-Cr-Mo alloy

(ASTM [-75)

Porous coated N/A

46mm-64mm N/A (in 2mm increments)

36mm-54mm N/A

Superfinished surface N/A

I8

[able I: Similarities and Differences avlatrix (conti..

IntendedUse/Indicationsfor Use:

Total hip replacement Same Total hip arthroplastN The Ultinma IUipolarprocedures for patients for reduction or relict Head Adapter Sleeve issuffering severe pain and of pain and/or indicated for use indisability, improved hip fumnction conjunction with aIndicated for rheumatoid Indicated for trodulair hip femoralarthritis. osteoarthritis, post- osteoarthritis. stem in partial hiptraumatic arthritis, collagen avascular necrosis, replacement proceduresdisorders, avascular anikylosis. protrusio tor patients sufferingnecrosis, non-union of acetabuli. painful hp severe pain andfemoral fractures. dysplasia. rheumatoid disability due tocongenital hip dysplasia~ arthritis. correction of femoral fractures.slipped capital epiphysis functional deformity. avascular necrosis ofand disability due to and revision the femoral head.previous fusion, where bone procedures where osteoarthritis, or otherstock is inadequate for other other treatments or abnormalities, wherereconstruction techniques. devices have failed, the major pathology

affects the femoralhead, the acetabularcavity is normal and notdeformed or weakened,and acetabularreplacement is notrequired or desireable.

Sterilization:

Table 2: Predicate Devices ______ _________

Name Material 510(k) Clearance DateDePuy Pinnacle Metal-on- Metal Liner: Wrought CoCrMo K003523 December 13, 2000

Metal Acetabular Cup Liner Alloy K002883 October 13, 2000_____ _____ _____ ____A STM F-1537 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _

Wright Medical Transcend Cast High Carbon CoCrMo alloy K02 1349 July 1, 2002

Articulation System ASTM F-75 ___________________

DePuy UltinmaUnipolar Head Wrought CoCrMo alloy K965 156 January 24, 1997and Ad-apter Sleeves ASTM F-1537 ______ ___________

Copies of the above clearance letters are provided at Exhibit 6.

B. BASIS OF SUBSTANTIAL EQUIVALENCY:

The basis for substantial equivalence between the proposed DePuy ASR fm Modular Acetabular CupSystem, the DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners, the Wright Medical MetalTRANSCEND Articulation System, and the DePuy Ultima Unipolar Adapter Sleeves is the similaritiesin design, material composition, and intended use/indications for use.

DePuy believes the DePuy ASRTm Modular Acetabular Cup System to be substantially equivalent to theDePuy Pinnacle Metal-on-Metal Acetabular Cup Liners (cleared in K(002883 & K00352 3'y the WrightMedical Metal TRANSCEND Articulation System (cleared in K02 1349) and the DePu'g (I ItimaUnipolar Adapter Sleeves (cleared in K965 156).

19

(b) (4)

EXHIBIT 1

List of Devices

20

DePuy ASRTM Modular Acetabular System

Description Uni Femoral Head Size 39mm Uni Femoral Head Size 41 mm

Uni Femoral Head Size 43mm












Acetabnlar Shell size 44mm

Acetabular Shell size 46mm

Acetabular Shell size 48mm Acetabular Shell size 50mm


Acetabular Shell size 54

Acetabular Shell size 56560xODx


Acetabular Shell si 60mm

Acetabular Shel ize62

Acetabular She size 64mm

Acetabular hell size 66mm

Acetabu Shell size 68mm

Acetaular Shell size 70mm

Taper leeve Adapters 12/14 +1.5 ±1.5mm neckIng, 12/14 taper AeSleeve Adapters 12/14 ±5 ±5mm neckIng, 12/14 taper

leeve A 12/14 8.5 +8.5mm neck6Ing, 12/14 taper

Catalog Numn r PartNumber 9998001 999890239

999890241

999890243

9900145 999890245

04 999890246

999800147 999890247

999800149 999890249

999890251

999800153 999890253

999800155 999890255 999800157 999890257

999800159 999890259

999800161 999890261

999800163 999890263

999803944 999800744

999804146 999800746

999804348 999800748 999804550 999800750

999804652 999800752

999804754 999800754

999804956 999800756

999805158 999800758

999805360 999800760

999805562 999800762

999805764 999800764

999805966 999800766

999806168 999800768

999806370 999800770

999800102 999800312

999800105 999800315

999800108 999800318

Sizing 38.5 00 40.5 00

42.5 OD

44.5

45.5

46.5 OD

48.5 00

50.50D999800151

52.5 OD/

54.49 /

56.4800D

50.4650D

0.4400

62.43

44 00 x 38.6 ID

4600 x 40.60 1D

48 OD x 42.60 ID

50 00 x 44.60 ID

52 00 x 45.60 ID

54 00 x 46.60 ID

48.60 ID

58OD x 50.60 ID

60 OD x 52.60 ID

x 54.600a m

64 OD x 56.60 ID

66 OD x 58.60 ID

68 OD x 60.60 ID

70 OD x 62.60 ID

Aah se

21

__________ ______________

____

______________________

___________

_________________________

Compatible Components List

The following are a representative sample of taper adapter sleeve and femoral stemn compatible components for the DePuy ASRTh Modular Acetabular System, and should not be taken as a complete listing.

Femoral stem compatible components are limited to stems manufactured of Cobalt Chrome Molybdenum alloy or Titanium alloy, and having taper sizes of 11/13 or 12/14. This limitation corresponds to the listed taper sleeve adapter styles manufactured from Cobalt Chrome alloy.

Description Material Taper Catalog Number PartNumber 510(k)Ultima Unipolar Head CoCrMo 1/3852621 852621 K965 156 Adapter Sleeve +Omm 1/24/97 Ultima Unipolar Head CoCrMo 11/13 852622 852622 K965 156 Adapter Sleeve +6mm 1/24/97 Ulitima Unipolar Head CoCrMo 11/13 852623 852623 K965 156 Adapter Sleeve +12mmn 1/24/97 AML Hip Stem CoCrMo 12/14 1554-01-105 1554-01-105 K012364

~~~10/19/01Prodigy Hip Stem CoCrMo 12/14 1520-16-050 1520-16-050 K000207

1520-17-050 1520-17-050 2/04/00 Replica Hip Stem CoCrMo 12/14 1530-32-000 1530-32-000 K(934334

1530-33-000 1530-33-000 12/21/94 Vision Solution Std CoCrMo 12/14 1571-02-000 1571-02-000 K953703

_____ ____ 2/01/96 Summit Porous Hip Stem Ti 12/14 1570-01-070 1570-01-070 K001991

8/25/00 Trilock Std Hip Stem CoCrMo 12/14 1012-01-063 1012-01-063 K(001982

____ ___ ____ ___ ___ ____ ___ 7/2 6/0 0 Endurance Total Hip Stem CoCrMO 12/14 1521-01-000

___

152 1-01-000 K(942370 ~~~~~~~~~~~11/10/94

Luster Total Hip Stem CoCrMo 12/14 1521-80-001 152 1-80-001 K(983 136 _________________________ __________11/2 5/98

Summit Cemented Hip Stem CoCrMo 12/14 1570-06-080 1570-06-080 1(023453 ~~~~~~~~~~11/13/02

Uni-Rom Hip Stem Ti 11/13 8-71664733 K(974331 85-5872 664734 2/06/98 85-5873 664735 85-5874 664736

SROMHipStem Ti 11/13 56-3514 612195 K851422 56-3516 612196 9/18/85

22

EXHIBIT 2

Engineering Drawings

2q3

23

~~~~~~~~~~~~~~~~~~'r-

~~~~~~~~~~~~~~~

(b) (4)

~~~~~~~~~~9

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

(b) (4)

(b) (4)

~~~~~~~~~~~~~0

~~~~~~~~~~3a

9

(b) (4)

(b) (4)

Previously Cleared Device Drawings (Sample)

3cc 29

~~~~~~~~~~~~~~~~~~~3

(b) (4)

(b) (4)

c/

(b) (4)

(b) (4)

EXHIBIT 3

Labels & Package Insert

3o6 35

Draft IFU

Total Hip System-DePuy ASR TM Modular Acetabular Cup System

For Single Use Only

Sterilized by gamma irradiation

Caution: Federal Law (USA) restricts this device to sale by or on the order of a

physician.

Description M Modular Acetabular Cup System is comprised of a metal acetabularThe DePuy ASR T

shell, a metal unipolar femoral head, and a metal taper sleeve adapter. The components

are part of a modular system for use in total hip replacement. The acetabular component

is a metal alloy one-piece cup with an outer surface consisting of a porous coating with The acetabular component articulatesthe addition of a hydroxyapatite (HA) coating.

The taper sleeve adapterswith interchangeable unipolar heads up to 63mm in diameter.

are used with the unipolar heads and mate with corresponding femoral stem tapers.

Indications and Usage The DePuy ASRT M Modular Acetabular Cup System is indicated for use in total hip

severe pain and disability due to structuralreplacement procedures for patients suffering

damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis,

collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the

prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital

femoral epiphysis and disability due to previous fusion, where bone stock is inadequate

for other reconstruction techniques.

Porocoat® Porous Coated Components Porocoat® porous coated femoral hip stem and metal backed acetabular cup total hip

use with fixation provided by biological tissuecomponents are indicated for cementless ingrowth into the porous coating or for cemented use in which the porous coating serves

as a means to augment the fixation of the prosthesis to the bone cement.

Warning: Use only DePuy modular femoral heads with DePuy femoral stems. The taper

size of the femoral head MUST be matched to the taper size of the femoral stem.

Information for Use An instrumentation system, as well as a system of trial components, is available to assure

proper fit an alignment of the prosthesis. Correct fit and alignment will reduce stresses at

interface surfaces to enhance implant fixation. The surgeon should refer to the

appropriate surgical technique manual details on the use of the instrument system and

This manual is available from your local DePuy salesimplantation of the prosthesis. representative or distributor.

3o 36

Contraindications Use is contraindicated in cases with active or recent joint sepsis, insufficient bone stock,

marked atrophy or deformity in the upper femur, skeletal immaturity, or where loss of

musculature or neuromuscular disease would render the procedure unjustifiable.

Warnings Improper prosthesis selection or alignment, inadequate fixation, use where

contraindicated or in patients whose medical, physical, mental or occupational conditions

will likely result in extreme stresses to the implant may result in premature failure due to

loosening, fracture or wear. Postoperative care is extremely important. The patient

should be instructed on the limitations of the device and should be cautioned regarding

load bearing, ranges of motion and activity levels permissible. Early motion and load

bearing should be carefully monitored.

This implant should not be used with other manufactures' components. Use of

components other than those recommended could lead to loosening, wear fracture during

assembly and premature failure.

Precautions Do not openTo prevent contamination of this prosthesis, keep free of lint and powders.

Do not place the implant in contact with prepared bone surfacethe package until surgery. before the final decision to implant has been made.

An implant should never be re-used. Any implant, once used, should be discarded. Even

though it appears undamaged, it may have small defects and internal stress patterns that

may lead to failure. Likewise, a new implant should be handled carefully to avoid damage that could

compromise the mechanical integrity of the device and cause early failure or loosening.

The wear rate of prosthesis contact surfaces is greatly accelerated if loose fragments of

bone cement become detached and act as an abrasive in the bearing surfaces. When

using bone cement, care should be taken to remove all excess cement from the periphery

of the implant. The highly polished inner diameter of the acetabular shell and outer diameter of the

femoral head should not come into contact with abrasive surfaces, as this may damage

the component and affect performance. In addition, all mating surfaces should be clean

before assembly to ensure proper seating.

Adverse Effects Peripheral neuropathy, deep wound infection, and heterotopic bone formation have been

reported following hip replacements. Subclinical nerve damage has also been reported Dislocation and subluxationmore frequently, often associated with surgical trauma.

resulting from improper positioning and/or muscle and fibrous tissue laxity may also

occur, as may loosening and subsequent failure of the total hip prosthesis.

Histological reactions have been reported as an apparent response to exposure to a

foreign material. The actual clinical significance of these reactions is unknown. In situations where boneImplanted metal alloys release metallic ions into the body.

cement is not used, higher ion release due to increased surface area of a porous coated

prosthesis is possible. There have been reports of failure of bone to grow into porous surfaces and fix

components. Shedding or fragmentation of the porous surface has been reported, with Radiolucencies of bonepotential for release of metallic debris into the joint space.

37 37

adjacent to porous surfaces have been noted, although the clinical significance of this

observation is uncertain in many cases.

Serious adverse effects may necessitate surgical intervention.

Sterility and Handling The components of the DePuyTM ASR Modular Acetabular Cup System are supplied

individually packaged and sterile by exposure to gamma irradiation.

Remove from the package using accepted aseptic technique only after the correct size has

been determined.

DO NOT RESTERILIZE and DO NO USE if the package is damaged or broken

and sterility may be compromised. Components may not resterilized by the hospital because of the possibility of damaging

the articulating and interfacing surfaces of the implant and/or damaging or contaminating

the porous surface. The care and handling of porous coated implants demands greater

attention because of the increased potential for particulate and microbiological

contamination. Body fluids, tissues and particulate matter adhere to the beaded surface.

Therefore, it is critical to minimize handling of the prosthesis.

The package should be opened only after the correct size has been determined, as opened

packages may not be returned for credit. Further information is available from your DePuy representative on request.

38

IFU For Previously Cleared

Ultima Unipolar Taper Sleeve

31/ 39

0902-00-701 Rev. B, 11/03

FOR THE PERSONAL ATTENTION OF THE SURGEON AND OPERATING ROOM STAFF

ZUR PERSONLICHEN KENNITNISNAHME DURCH DEN OPERIERENDEN CHIRURGEN UND DAS OPERATIONS-PERSONAL

A LATTENTION PARTICULIERE DU CHIRURGIEN ET DU PERSONNEL DE BLOC OPERATOIRE

ALLATTENZIONE DEL CHIRURGO E DEGLI ASSISTENTI DI SALA OPERATORIA

PARA LA ATENCION PERSONAL DEL CIRUJANO Y DEL PERSONAL DEL QUIROFANO

PARA A ATENQAO PESSOAL DO CIRURGIAO E DO PESSOAL DA SALA DE OPERAQ6ES

FIA THN RPOZflIKH ENHMEPQZH TOY XEIPOYPrOY KAI TOY RPOIOIRIKOY TOY XEIPOYPrEIOY

PERSOONLIJK MEMOVOOR DE CHIRURG EN HET PERSONEEL VAN DE OK

ATT.: KIRURGEN OG OPERATIONSSTUENS PERSONALE PERSONLIGT

FOR ORTOPEDENS OCH OPERATIONSPERSONALENS KANNEDOM

TIEDOKSI LEIKKAAVALLE KIRURGILLE JA LEIKKAUSSALINHENKILOST6LLE

leuoy Orthopaedics. nc. OPoW LtdI IternatIonal ______________________700Ortlopaedir SI Anthonyr Drime fRted

WaAersraw 0 L$ll $00 eI. Leeds USA Englond Tel:cli0k 36814t 2700461TI +44L(113

FIe +44 il13)272Idel

0902-00-701 Rev. B, 11103

TOTAL HIP PROSTHESIS, SELF-CENTERINGTM HIP OAIKH nPOGEIH IIXIOY, AYTOKENTPAPIIMENH PROSTHESIS AND HEMI-HIP PROSTHESIS [POeEIH IIXIOY SELF-CENTERING

T

KAI

HOFTTOTALPROTHESE, SELF-CENTERING"' MEPIKH IPOGEI IZXIOY T

HUFTPROTHESE UND HEMI-HUFTPROTHESE TOTALE HEUPPROTHESE, SELF-CENTERING r PROTHESETOTALE CE HANCHE, DE LA HEUPPROTIHESE EN HEMIARTROPLASTIEKVOOR

PROTHESE DE HANCHE SELF-CENTERINGTM ET DE HEUP DE LA PROTHESE PARTIELLE DE HANCHE KOMPLET HOFTEPROTESE, SELF-CENTERINGTM

PROTESITOTALE DELL'ANCA, PROTESI HOFTEPROTESE HALVHOFTEPROTESE DELLANCA SELF-ENTERINGM E PROTESI TOTAL H6FTPROTES, SELF-CENTERINGT.

PARZIALE DELL'ANCA HOFTPROTES OCH HALV HOFTPROTES T

PROTESIS DE CADERA TOTAL, PROTESIS DE KOKO LONKAN PROTEESI, SELF-CENTERING ' CADERA SELF-CENTERINGTM (AUTOCENTRANTE) LONKKAPROTEESI JA LONKAN PUOLIPROTEESI

Y DE CADERA PARCIAL

PRCTESE TOTAL DAANCA, PRCTESE DAANCA SELF-CENTERING~m E PROTESE PARCIAL DAANCA

INSTRUCTIONS FOR USE

eAUTION: Federal Las (USA) reatrinlc this devicet0 sale by or on the order fta physician. DEVICEDESCRIPTION TOTAL HIP PROSTHESIS A Total Hip P rontdefin in compe..d of indrriduaaly packaged mtetl tereral hie sler. mOdellr metal or ceramic facoal head and 2 piece metal backed UlIra HPo Moelealar Weight Polyethylen . e UHM(P}. casrrohi or -etal or all UHWP ace E t declird to replace abularcorpoertl

he - ailax oureace 0joi.natural T

oe the lipM

OELF-CENTERING HIP PROSTHESIS A S.lf-Cereteirr Hip Prosthoeis isa hemti-hip e consisting- and pla retainina ring lobecomponen a ea rrieanl'ic CUp aid an UHMWPE neet stic area wha Denuy ferotal hip trom and modular metalball with cheat dimater correepondingto the irinide diameter lofh Self- Ceteenn Hip polyethylee trot - eetoral head erdr eCk in beri-tip replacement. The Sl- Ceniterira Hip prosthesi s aaso ased as pad or aemplace thre Total Hip PreOthe.isA hrese ir onjurction ritha UHMWPtE harina . ct.I, pordl- to the oalnide diarretercart,,, lattce inside diameter

f IhI metallic cap that in utilized. The UHMWPE inedr is dsigned wit easliding crollar; the collar chanrel intrlOklo and eli expands at the ailt as it elide tto modular fernoral art lhe orig inal shape. The metal Sapcompotentover the equaton of head spririgs bak It it then sriap-looks over the UHMWPE ricet as-embly. Trial redaction Is ac-omplihedwith. rtel trial caps ard ... whhicS are idertieat ir dimension to the iotplerltable comporerts to be aced HEMI-HIP PROSTHESIS AHemi-Hipprmstheris is -Toprdeda f metalenrcraf stemard hod deaiaed replao ther h n lead td neh itaraleomor nemiarthloplartyl. INTENOED USEJINDICATIONO TOTAL HIP PROSTHESIS Tttal hip artokroplaste reduce Ie damaed lip in articulatn iisinteeded to previde inreasied patiert tlbilty ard pair by replacirig j i reretheteisevidece et support hcomponents Total hn replaeer tioiredteat-d ie the f nkiertsonlrd boneItc -eatard ea

conditionsi Ar deey I r stecaroeti, erusati arthritic rtremarc Iahriin, oro-raIta Iartal ardier dinealod loirIII lip Clptei.

2. A SCaltr nerois Ce ekhe teeotal head. 3 Acate traumatic t lttet ernoral lead or teckfoorate a Failed pr.viou.s.ip surher/ incldirg tointreconrt-uetior irteal Il-ator. erthrod-io hrmiarthrFplaaty runaco replacement atPteplast

rtotal hip r eplaceerrt 5b Cedain carer oankyoesis.

t T ' ,rirnlfokt:~ioniellir

Pr neur-paeI,,er bblrri sneI sbdke oneks nppntdnill b.i.ur-I r fIljd iskttauma. tfrnsr ellki,1r I, kd reLktioker eller-aokmuleningnn"a nlerveoteol¥S sthleller lossnin impl.ntotet onsa en metol1nk knorronjoc. ellerqisbo nlrtnetnoragnennll-11 vo naceretent

9h perikllr

AInt lairelatiw Fertnnerirr§gevlennvrlsbcrtelnprrlcknr oiler Irebturer scm kan kr~ne internfiei<

4 Skeldor pO blodb~ieel obtenetnore<-nekane tchfmoralartarl. 11 , ,I n isolateredodei t enfemorerc rnee,pnrm veenoenter ebtureton elj proleatl

ubuion eller dinloleatton en hbfltedec till f~lid an inkorrekt vol so impleert~onrolk ~ere konlicenatict. inkorre~t posinionering ave kLomponenterron ¢hellen till l a m Il . .e eodelappker.bet-biler II klb

7. rlnnl, ri elier Irnkortnine Coden oktoella entremiteten. Tldlt pOstnparetiea

1jrnknrlslekdomer jeblusineblodpropp li ven],lu ngembohi non bjdetinlorbL 2. Feretnrnr onhlell erlknInIl Iopsom 3 Lnr feeneeennrrnog n obhe len at elekte. 4. Subluxerron one llslnbetlon.

Sent peetopenatina I Annlrtnergl~vntnehborlencreaked en tnendrtneth00 muskelepdrneirq, oibtlyetnirtgetherconsiktlig inoreopeeatiotorsoagninroogrookoroente. .I -olrrede problem mod do erla e bTO oh onbelledeknnppo enoikondebenl.ngd. fernral medial.ee.ing nob/ellen ipnilat ell, kbontralateral

mos kelp, ns 3. Feonrsel-ine~ annreolt~bladrktencreakad en trouma eller for coo belastnine. spenielit isenmband med otiltrenklige mrnogder benmoteriol pod

snoredad onteop<:trn. Lenderenten oidigoreo(perntioneoneo~n icteneperatinabroatecnbningprocednen reller Oeneenorptilon 4. OBlio 1)rm ennenn~rr bidno till nedbrnctolno en tinenireen nobf rpldiande I oscnir~aeoeenplarettet. oln

Ipnnrerkolanl, rkalkning ellerossifil Itet ken till mi.okaleda edrliertgtIet corI r-relnett.het. 0. Tranerrtirsbc~ronuOndot ipnilcnterle knot till fdljd en int ranperenin pcciniooerirngeanentreemiteten. ?. Sulreuoeeion Cnh dicloketion.

Kecmplikotioserens trekoens e Or narta h00renid enirenginkeoch ev~§ihetedrsd nid eh6rterkrrning renininner On nid pnironerperatescnc. ¥inliat tOenenrnorekteneTeennderm[e odr tet old plecening an enintereller nidpositicretinevnhe onkocmponentena~ sc~nhetrt art enidgsneektepiskt ben nob

~] atb~eet ooh/oe~loroosv rihetoatterbhtle tHIltndkligt neonmad.L~rogre o petratconntie. ObadlOtdefnoerlunobbknedor f~r infeeti oncer lososontoll eerih lrrmrrct mr ken coked tnedtas uppctdnridnersevsonspreoedoner LEVEtIANS

e beo~skroneoobuloneenl de haft tsbennponentneo Inoeroran in dinidneilt cob STERILT Ohnpaokede, orlekl nok sj~loerectmrnnn nob lnelohbbf All. neterni-veb ehk born,~penennensteniliserae g]encombest r~lnin ]. UHMWPE-ketnrsnentercteteeeeners mod aesplesme,etylenooid ellen ganome besttrlneer, online oppeilt pO ottertdrpenkningenserikeet Toaut komponentorno orfdrpckningen m henederleedo aseptisoko eriere betote del ent ko}rnekeetorto eless~1tO~in Foe nletllknonpeccrnn oent bcmpoeceten, net fnrpaooningee tbrefler reoek aebad eller em dot stehie imple<etene ecrigt rekenens§1err a b~edomninetonsen vain p~nerket, med orndO enneptebaet t~n encode ananodcice. beserst pa monte reneares one sterilJe*mrs innon den implonrelas. iOteljhetomadnedeost~endoinstnuk0ioner SKOLJNIMC/PFNGORfING

An~ndste~lLrmstepereatnvtten etler fysikelink soloin*snin0 eon b16elaognine en inepectetet. Bl~tlaqg under minst hemminater Terko produktent noedelbte. Inspekteen alia prodakter edne otnenilinenir n§ STERCLICEPING(ren~altkaepneenter}

iOmen metealkot~npnene mdctecsterilieres, nar seebliserine en sko en liqo nedensebende porometrer, benteone qoranterod sterilitetenind ISALIpb

Met<ed CrkeI Temperatu' Epeaneelegstid Anne Fdrmakom t32 "C iae

ANMd[Latpuihmn leonon orrilinetin§eepcedon Bet Or oikt err ponoonrdo mro[smterOlsho0, m~oteCrtat pOpooode eden. onknitink peoceespaeemertt f onr serj ~klid into~ntninscteniliserineselotrUstniraonlhpnsd.ek~lestkocintf 00penonetcrn Oretr~nadeb rtieon s experter r~st enileserticontronnesert

Drettetot nrt ploeesen n~valsore does tieleorlillipre 00 ken~arnvndes oem na tillerst i dol oeh epetetbaetbe ekekanno benlyrkee. $nnabrelteerilseri speollke sirhuebbonn promo. OS~l Aqeand inoeCngstentliseoing teer keeramiska tofemerakuler otter prcotsee. Omstentisero into UHMWPE kampnonentr. Aneond into deesa knmponentet oemden sterile ferpenkningen f~nefatlee cane skenad.d

IAYTTOOHJEET

HUOMAUTIJS: USArn Itltttevaltolakn er eaj ittaa ndliden cettcleien myycles nien, oelo nhidec hank kiminect an e1littua cain laokonreilie in muli.e henekitbitte I5000rln mO~r~yksestO. LAITTEEN KUVAUS KOKO LONfKAJO PROTEESI Kobe lackee prectci Inoecten nkeitt~iepebatuete metellieeste reisiloec Innkbaecceete, meduleeniceete menetaliebototei bkOrboei~tearnii~leen poontaoje lobe beborleec elteoseuuimolebppliseotoa polpet eenisto IUHMWFE}oelmiseeesstetelibebsiioseineste metctlliranhist eisectake ra$et itreroili~eetoeinultroeueritnelobyyticeat potyeotoniste IUIAMWpEInolmitelelieta Ionbkamnaljnbbo-osiste. joeko on tounr~eilota brkoocaaaan tcnkbanioelenrscenncllieenTM

niocipinrar.SELF-CENTERING-LONKKApFIOTEESI lrnnkrskitty¥O leekkbeprnceei en peblen Iockee ca. joke benetnerrlotolliseotna kopicre joeult roei ms pelyeteernistooealeisrtoeLUto~olekyplinoestupouonsesesa ja muooiseste ridicmkenastaejacstoen terletites kdnttoo DePnpy-n reisiteun leckkeesar jaemodeleeneer meteailipotleronee ic~,jiden peon nalbaisija vestceleiekeekiteyoan oenan pelpet eecisoo eleniset sisahetkeisiiee, Sitokaytetoon bonsaemaean ur0pa01jet n apotusosarc reisilso keelee reeler lenkes keoramisessa. ltcesekebilrpyio ernkkprneteesia kdytet~noyreode 010kk oke lonkeec bokoenacv pret$eeie koyenena$sc pndonsa UHiMWpEsta valloiseeun toakipinneer bansce,ionbe sisorealkaeisije nestee koytenttnon neettalikepir olksltelkeieije. UHMWPEecrooelminlettusupotueoo$or cuuceitetlet lubiess Iselaeneeumi,aott siiea on liobkuoobenooaieen inUnrnees Paulut. Knob~s uann kebdalta, ken so yii in paautee~lten lkoupe-diceen muetoensae MOetailiesno boppiosa ILobbiutuooilenlioked modunaanserc misilaun peon ebnaaetten siao UHMWPEee no Sijoill eon osoettemisen tapaheso mretellisi lie koebtepeille ja upetoussille, vlm~istetoc upeoousea-asenreehmer podle. bn~keilem'nnen joidec bebe neetaa eeenrenevien onionknkee. LONKAN PUOLIPROTEESI Lookrn peniipnneeei ~onnett eunoet soreitltet jl~isoste torisinoctajapallnsta. lotke oren boetreonon Isocnellinen neisiluo too ie koala peoli~keen

roeanmooa ucleibkeebeeessa KAYTT6}TARKOCTUS/IOOIKAJATIOT KOKOLONKML PROTEESI Kneeo Iocean mecoeasloikkdus reedoon pehtiloae liiekenounder lisaamisekci je blevnt nelecennt~ioiki keotaroaila eahieni0tturct loekkeerioel petrieilia, joulea on elitntnvoitareveltt olout irt~Iane ei 10ke ecei. Kebo lenkan prat eesi en tarekeitetto boptettonoksi ceuteddoisse iosa

kItEtoickinoilionia/tel nemmeeterot rnid. jocke en aibeopacnt ninelnolebdoc$ tmrneooottirn tiioetlulchduc, inelerntasyynineei Ionkon ketitpsbeitio.

2. peiciloocpeon nnieseorctor buelie. 3. Akeetti troomon elieentotam neisilson nOpan tel koston martuesa. 4. Aikaisermpi epeonnisotonut letebbeeioelen loikkons, tisoiree biirnctysn omelet iapkietyeslcikkaus. penlittaineen nseooseleibkoee.$pienoc

bonsovnrenuoscu$eibksa$ eelkebe ockean benlanneprobed i 0. Tinertinniej*ykietymatapouese

porocoatte huskeiSolla pinnoiteella kesitellt sesat Peoeoncal. knoboleslle enir~neninteelen eck onar elan on tetkentettou kO-lirttplt reisileoun tenkkooorni ia metailioahvisteiner lorekomoljaero kepin ke baytett~riksi tilmer sementoirti ia biicnitettooiksi nilin, etto kicot~irer kedebosnknee, keincelioebeieen pinreoieleeceeetoi bkOey~n~eitva serTenteincicken=no, jaible huokobene~ pile t oienii teparca 1i0ata proteesin kiinrnitoyeisoo luusennenooiir. Samantnloidut aeont

neisl¥ri jo renkbomorjonkepis boon lonkeeneon.t inisee on kd¥ttd~br tro~tbet~tt tetvk~tsn rneibie'Veir] sceertolteuerne on O

Ei-huoksiSelto pinnoitteetlo poinomnolhokuinnitettcilt tai setmetctaiduotcain Ei-Osekeioerll picceinteelle ktSite~rrn reisiluoen vatreiprotne.sioesr inis~seen rnirmie 'vole peniete biinkitpknnt ~eseeocoituunberetnclV en yeel toebeitetto biinenitetnt~ikei ntie boalekyetatvibsi kenese.pndeticmella lilrnen oernentici lunaseenenteoirnir Koetr'atikatta pelentelttet utreisiessnt iKerenreiibolte preteesin ore tareoitettlo inen somentointia ia biinnitettonvikeipuenslemalle.pinreniestot reiniyreeren keoytettl'oiksi

H UOMtAUThS. ALA KAYrA LUUSEMEMNTTIA PINH OITETUN PROTEES1N KIIPINITtAMISEEN. KERMACIrKALLA Moduatorisotretniteoun cit Ja tsnnlkkamalatkkc-eeat

euy merelliset tel kereemicer modelaarisel reinilsoue pO~t on tanbeitentu boytett~nibsi BePap:n reisiworciecienbercea. Lcioenokmliebkk boavateenDePo¥:s eakeiesaisellamsetallieahnoietcicesteUOHMWPE:sIOoalmisrelulle, beesmiselle tel m~etalliseallotoai kekeraan UHMWPOEtOi neimietetelle iernkbomellakkokuppieeella, jess naldnistettuaketraamiste kecanasa pinteaa lorkeb~ytetO~nUHMWPeE:lkSt tai metrtliste ieltohabkicije easle medaleericee teisilnocnpee.Ibebaikaisfej.

VAROITUS:K~yti coinOepuly~nCo-Ce-Mo- eelkeramiikksatamitstiisla rneleeuac Ipiles yrleoi DCpIW enisllute cornsienkeenss. Roisilaun p~ietnetarln keor. ON VASTATTAVA rilsiluun oerrenkartion kokca. SELF-CENTERING-LONKKAPROTEESIJA LONKAN PUOUPROTEESI Self- Cectcmeg-lnonlkkapeeteeeie Ia lankee psslipreeteit en terkoiltetio ktoentntosibei penlittoiseeto lereken maeosleslkbok~Leese~, 10150on nedieteita tiiltoeeOta¥=tslennllisect a lenkemelinknsle Ia marisivarerm m~rdtooo Petolit tebkemisebsiIC esettomisekei tiirtteeesteinileunur toisee lockr~k

euoonsleikbaukbernirndikeetoiteilcool: I Anercl rielilean yeentai koautEc marturee, ieee ei voide koncolle aecetea cijllerrer tel borneo sinic~ehll biienistksellO.

2. Lneken murtemoner o~eiepeesl eel recites sisoise1to kiirnieytdksllo m, vodds brncello3ecettn eioClelceen n eisiloenr 3. Veti~onrcnet koeiarlnlusen~ma

4. Reiniloen keulan mor~emile biincittpmetajlomiren. 5. Tineryt vnhset~n keenest jar dcisieuu boslon mru 0. Peppeuttaoneninnlnnlehdee. eiar/itee keooata.icka bedietos eaic meoiluun rekon, lolecislesklEemeino~jkkeea 7. Taeedinkono bohon liiteey vain relilieue ponbaulo la/tel proksimealicer reisilse, lone neidebc bemto pue~litteicello loekon

iteeeknrtone okkpotecbensest to ybsip~iset meinileun reel en teebeitotte kennetl~aoobo kebe lenkon oente~platiosaeponiloen liikkeouuden lrkeoemiseksija been potilaille, coilla riite~s~sti trmetnO noute,letna to 00vol rueeainur vhentdmiseks ikervaamoile ¥hin§Lnittunut leekkanmnet or koeretee~se ynhnoo UHNIWPEeta nolenieste ~teutkipinnsre kensee, lje casteskayete$toavon bopin lllnhbelkeisiieaa cnkanoahlkaiclij mteeattik Key{t baeklocket pretecein bacosoon tenkoinettn kep-t ec{ivo<sl nseureoieeaoileieSEt:

FnEitrainrkrcliacIn~telnemmeeternt clod. joeba en elheuttonot ninvtulehdno reineetnle nnoelreeumeeneumoottirteen ede, ci eynnenneerne lonbonbenitysneitlo.

P a- Pill.C.U . -..... pdd ,by f.,- aIFh',Iflh fl I l I .d eb aIIY G ~ Sqp I - " f U,.,IHSq - ,' ....

Cementd Components.hi

Non-Por..us Coaled Pres FlI -rCe-rNeed C.., ...erls

CAUTJO. DO NOT USE BOINE CEMENT FOR FIXATION OF A CERAMIC COATED PROSITHESiS. Modular FmRa-I Heads and Acetabular Cottrlpannt A Needyl IltEta or Ieoyl bead Is rob used tooth the DaFoy teecra strr c/scralrll. TheII Is nI eeylollndaaitelmedoloeleso aceaboUIm

- beaeic suntove 1 I 1l d -I dam...... to rhe, outid dIamteio the reodh II lnet-~ld bead that is utiizd. sith an nsde rnpvld ia

SELF-CENTERING HIP PIOSTIESIS AND HEMI-HIP PROSTHESIS

2._FeIcI'rIrdlrpalaI'llr'lcutbbh ptbatcaanotepmbIatIthdaoedIII h a I, beuY, .... dteateto ITerI 3. -a",aarncet Ipmdoifte oralbeac 4. 'en-uetlea tenulea" ecoes ICertin bige soboap sen erecorl seab b1Icdturpa Iin eldrlyhitld te

.... ofd Hmetlidoe loot Is tittoe Us inItoa PI replaaemer ts Iin.iotd In the follouing aditinl Itinstbe . conF~d AseunrerlyIpItu and/er." dhIsald foirt 1 trom truat otbi., ehematid antlaiti, .t cg, IbI hipYOIIIteoartIrIdtiI. dypai.

2 . .Failed picunjoin tposttl. l etenna-IIII or, tota hip relaemntpeius hip sugr -tinai, artotdesis, slristnolsn

replacemet otor itb risks associated With the oar othpatetdi llImIted demand regardig acivity and bi, join leding oar be .. l ostd lone WARNINGS AND PRECAUTION sect ion.I This, inlde .. b.. l snippled. paients with maltItI igittnuavene tot whom again

CO NTRAI N D CATIDNd

3.IPoo bone qaI-. sI asosepooIs oNt., In the Iaocn t-"hem 1 oI tHe protheisoino, 051,1 be soodarable.Fmgtio or a

hemi-hipprosthesis.

WARNINGS MID PR.ECAUIONS CAUTION.

demonstrate t-hat, when aced With, UNIMPEAK euo cups. Itt..u stabildIzd N.,ne.tia aIr.ttlist loeI mohadsprduc or par-tinute, the tota ameuIt oIT part~iculateMremanondetemind. Because.I fimhitd cli cleat end preehilpinte the.... eNlee,

a tnpagsad or theud neee heue tgtetrials nampoteets from ditteree manu.aItInErs . mlanetm *Hip prostheis compo.net shoot -- Iebe rehlmptte. Esee though t.heimlant. appear utda RMa,the implant map hav

deveope Iminrscpl impertactpiantWhtshcoulI d feud to ailure.

*Guaityfono bone.stock it critica toes-hl reprcIma fIt'aion. of citfmrl aneW. Consilder bone g....n an d oher minthorna tehtl...... esreiatty w~he.tperormint hi srer, ta sea and support the tumora se..ent .,ot

CAUTION: Ten foilowin conditos iglryo t ocr ic, tend to Impos ecem loadin on the alltested iettemitl tlhemby1plain theI

5 ibeiho .fo tol.I .Y, 0. htbe or, dru addoton 71.Other diailte, as aplicale

CAUTION.TheIfoltIn yrditioro cigfd orRpIcor neettcdI1tend to adsenl attest the fillats of hip PRnptacen'enireplarto IMarked osteoporoii or poor bone stok. 2.Metboti d Orscteic phanmacoegica crestWI,,teadir to progressive . sappon.. ,Idfo theifeie fc,.isorder deteriOOi, of solid here

3 .. of genma or goa Isfeot on Hstr d. _enr dform-I tie lead in to impa d or itprope essItign,nc cII tue mplpire Ilotio 2.Teom of the opp...roins pore sorot-ins

0E.MI. ot oghr g.itsli.eI., knee sd acctes.dDsblte WHEN THE SURGEON DEFERMINES THAT HIP REPLAICEMENT IS THE PESO MVEDICAL OPTION AsYAIAPE AND DECIDES To USE THIS PROSTHESISIN APATIENT WHO.HAS ANYOFTHE AOOVE ONOEIONSOR.WHO ISShIMPLY YUNG ANDACTISE, IT IS IMERATTIETHAT THNEPATIENT tE NOTRUCTED ABOUT THE STRENGTHf LIMITATIONS OF THE MATERIALS USED IN THE DEVICE AND FOR IMPLANT

tATIONHAND THE RESULTANT NEED TO EUc REOUCE OR ELIMINATE ANY OF THE ASQsE COND ITIONS. TANTALLY LThecgicl, and Phlpetpetlde T.snIemeT. of Ithepatiet must be gnIod out with doe .I for, a llnoisn condItins Mentalatttdesosidat. II

Mt~pTh Itor irneplerttpicaig falr..iF 1 lid

Fposiio,fraser, gdowen. of 1.The tuciona tfi espTciancy or p ImpaII Is. CI proatet, netceanl pitodlobihd.imlants. The Idile hoteicp i

INFO RMATION FOR USE

THE SURGEON SHOULD DISCUSS ALL PHYSICAL AND MENTAL U MITTATIONO TOL THE PATIENT OF THE PARTICULAR AND ALL AOPECTSE SRER.. Y AND THE PRCSETHESO mWTH THE PATIENT cEEORE SURGERY. The disosin should oclde the limitain and posibte.

Th vpAdiisit epacren. an tphensl-n tofolo tbe tch~ hinstucions.. p-10 -pentv, pa.. icularl in regar to at.,co p...itdIII1II

gIne darin developmer hipTh p.M-tsen. baranans1 h oId ia aeo any bIip prshessbeo teChe oI moo should.ntba .hv0

ltdrecvmmesdethatcamponentsatleao oneoionlergerosd ,O .. 11II peraseI LhdeterinedphAvalabteatsrgnratonsaemleraneepe b

potheia.p Be r imprlontIIgIorami amral head the male taper on the,- minerlhse IbId be wiped -a atone blood, hone chip or other11 rToial. FoNeigr pateriabetwee IThe-daic taper may itPod.r pen. seatin heaId on the roig II head and IThe f-morat stemh .11 stem. Thi coul d aenoth the pertanang of the temra head or H mechaismipbetasthe looin the fdWoro head urd the tmo~ra stem. Ed not

Residff ti ry mmb anes Inc~r w.t imlnH iaio. lntpIoI n -plaonneth or. posit ioning l imlat mop-reatIraasomo sefflectionl.

hip reFplace il of .west tea reaI in ineoblity ad/erd dtsiocaio ITe jon. Prio to oloore th surcl- sit sha.deI I Il of bane boneF-d LHr etcbeIhca o-Nant hips. net..aneous ceen 0500 eoIc her. Foreig patcLenaI Tthtmnalplori orIetraie/latie inrunta. reap scone euvesio wear. Range on motiv huLd be thnrasaftt ehhesb Ianm, oe

Pastopeatic -3 IQ IItrfsiadl...rete bath paient heso... en~ insrecios ttg is ectrm-l imotant. Ae...ptod Pasices- heald be lati edo.Is an d watnh dootopertive care.

.1- on the weight beseng witd~ cruthes and UPate a macadple isId~ activiiesatia pitw iIer with one huId beoei, ei rnion eonisieneere id h .vezvoeoz l Yitroelnsrurnscdnactacii ent h d.-. .. . Ud.,I.svesfhr Iis I- Iar as'Uu..o.h..M. II ss.

(50I ooiIs, peptteipto meaplikeot oo'dap noo lie optile ille 100~IIP.. kiistts kiesiit soelstIob enIl Ipokaise itedikntsLo

ktst-.tioeI castos -Cool oodapt ttmlA- (Celpokota AOITUi ITi- i-linalittovLOL aIjIOl JA VAROTOIME~ITEE kL polilpe blue IlkIi CC nejnlsIlii kuvandenlbhot. pleoomloeI. tt, paene ol,1meo.laao Oo-mTlovesii. K0NTRAI..NDIMTIOT Sootosoat bl -1 k000 dtaaii a. psol11iptotenin ahl1.1eot It lances holo

IIIIt jlt , tlhdus.en pi- Coline ta Ptemie 2Lie- to lil p-lot,.1dcy ntepmsi, Ocmot lol hstnliei l~b.ke We ciiihokItvol-I os ... eaep.... a IILLJ ... keiseo el.iiseptn

ii5tLtbi e cI sic I I eatn oteoseso,.se biegittictinitc aJi. ioeclotiryntt ti'll nIcikttiiolutlle, mabonpaata ette ,

jd-~~~~~~~~~~~~isttilittl-otion IJ11-111111 oIl.a da Id'dtL

a1 .. esosept stbmslntatbusstk bps1I - -- a l-onken novpleidl Cik.II 1 I eate hokt.s sClu lsnhsealotalooot..cn .ataaedyiliiI-pe oneaaia j. atnii~ -J, -onC.a-sltlb lta eIta**5 oiite Pt COiit-mise Co-insLLIocoloelintet politeps ..I -nanma-aslieaeoeoa

I6. IL IbI . I d op Ineid-ln sa-p Ot hosie ko ittn.ttpoit sItKtoistplsetktIaidispitaia ole koisstt-. Coislikb-ob-csp, elk Lbl bl ci ida Ckcttee oiles kilt U.t~ttEsoeMi otettaCIetI Ita metalIahit,ttetl U.heWpE Lt 1isttieokupien salm

Cocoic 6,L- 11 I 170MAA cia eteiIte .c Cistoitii katkei paleotopl d koaiolde,sic tootidekol kpoiond N-00Ccal btet htniipelle hemp eaten

1610isisitliteiinltotmienmeooat. hd oaemi.acor oiJ haltkiltpa tsbhae"t, I.Pi. ostelp - loeeroepa nieo

eel insi... iebb ilb iii bet aie Idbi 5

.no.isilun a, dsl o* ikcnjuo1iakiljst calmbitnu pSt peilni iisot...klmaijkksiatoiaslstsJane Chinin ktttostu

hkasalsif.... t-i colds m5c15..ako tiakksto sian. kimlitee is osikliiloon kakemus en rjllita pithin bialagisis

*Ed paIlm ispajo pso,I ImlNtPIMisnios..lrnll keulotelo Wimsnt tl ko....is oiso koskeank5$t5....sssskajsspi. * enkprtesl si ... k.sks.. sont.aalsudolon sikke ii impisniu.i.nIp.eLI.iitoec~lslInt .s..... .ll

*KtakatIPnsottlIts eels.1 kaonsktitkiin.k Keontossai ... kola. ecton pEseoi imptftti. ..55105 P. KiN..ptatttiont keen ito. an alaso same kuin PysPiil .. tn.. cn. npstn

* s. .lst.p.eI .s .cns .al.m.stN.t115,ltt tdct ."teel I5kc5I....... Id L,,4s.lstists ions ceid...t -amiste pnokindlssissst kllntltyslsn..n oisl... ca-o

La .tficepssist is mAlts tkti halt tos hankie onkin. oisioiLoikkse... teess robleltena.. o suts.si

ILi Call Osou tl poti .an lIIa eii, pain.

2- oomII-e -1 60.l.I

I AeI-oIi sea11id 1

7.hdINt saotst lice maccap. UMAt Sesieasa that ppi tel cdi I.ec Wk pioteodien iiitbses: -l~id .S.eiooe 0011 he.olietIIsibat kisesLe *-cIp I itcsprpoo Is i telc i. ii-1tdbl k 1,.0 I

lepim.1aiblidesmelito otW.,pipimlop dilopteci. ....keipsIpido Lice k1.P.,-t.I. 2.Jlkise.L eietl peieplptothept

I de bot elimedetumt, lat pe reeien ejonipo o siciine ta imoasts picetec apl m ootsaleco 5. OpElc..ieooieceiccc.. PePaInc.MILL .-. .d.db.- M~i"11.. II .~.

d.. mod, locab sleope. oei-epte to7.I,OytntiteieptoeaeI, ao oTesi~LIIoooooPeNbdoi, otitotlciitslsbilci

a. MeidctsIsetcsmpoei oct J.icil ploct Pi slo (704d(10701 AM-R 0TT6 LONKAN KORVAMVA LE IKCAUS ON RAMASLAA(INNALLINEN M OLSOA AIhTOOCiTO JA LtELEE LAFAI PATLM-KAIfLLATM PRO SELLAISELLE POTiLL JOLL-A Old JOICU YL.LAMAINITUISTATILOISTA TAI JO"A ONINTICSIA YKOINKORTAIOOOONi00 JA AKPIIVINMNONEHOCItOM)AN TIMKEAR E1TT POTILAALLE LAIllEO IOTUKdCEPAJAKERPROTAIN VALM KIINNITYKSESSA KAYTE1FLVAOEN MAATERIML0NOAHCUUDEPORJICTUKSISTA IO SIliP OIOTUVASTATARPEESTA VIhENT.IMPOISTAA JOKN LLA MAdNITUIPT TILOOT.

alikkaupta pepteavan o hoomipo kalkel pLctes lIst. potilaps epet...t.Potlsan bIteci . dseep topedetta pile ell slpe . . c.. oVeniot b1ke potae hood kksMrseekmhhsteospe bsodseee kicateis bltici,, cettop hidpPos lickoakace jlO~btitt toipechiptobtei tIp'm

L ilallsce loItet .ktsieu tel slielconti hMaidocepa tosetmas I shcettas sIIe tia nopeanpcstipco. Cok~b,e Iml . -l eteasimplotl In apeotppaaltaampopoe te .c popp.e uItac 1040 IIlop L.ickkeldeice toeneais Ithekl did I111%heebeltdMId teckellecs toisete.

0440 KOSKLPTELTO PsYYKKIJIpT RAL.JOIUISISTAJI IAIKInA LEIKKAUKSEENJA PROTEESE h1td LIITFO IST SEIKOISTA. Knokastoluspe on N.oppa 01. niveliT,11Ptaoloapotaipep ihepoca ,I~koaekpe -amaaLd.se..T-1is -eorekpct Ic ttt ttsdiaea elnrbil poid. lc entom phicit

KIPIJRG N O.ENN LEIN.LSJTA POTILAAN NANOSA KAIKISTA POTILMLLOE AIhEUTLOISTA `I,, S STA JA

kchtclttehNcI.i- dbiioceul pickaesbkbcc,obsNe. Kinoopi ditas -loii.e mi-oct -onccemecepie disiiis kahseoc esses col h.t s dtuepetocuhootti-lapelepplocp Ijipooo-~ lkkaestokiikls.I Tilttccctlst dbol~ctics actc.Cok~llitliceslottlo0 esetteopt.1.id Ikoec-i eanLci T.Nce-ma moT-eepet eploeps, padnnstlisilla kdiruigitl tasitctili opll- e, bum . bPtiIL. .

_oikkeakssobiksn. Ottoast Iisos ea tcikaobct.cllI op oseteolll pebioa pIpi kaI.coeoCi seon IlsIti mpsniaiI Aotemi ia pkcid rpilstt l Nlttimniani

keidlckkeheoelts-id-,noali piePeockolceid.tplcllj.

aikeae asciamitioo Tome seeptee opkte i1. pe n teeipetteso N esLb at peepI toirnietoan te tisa a. tlileacI Paicslobtsm P.seeIo Oucite pinle lCoscelupe oncelcttas kaskesteld melid. Octiadeoe macasIeRop. (II lactose I.acjpostcidbkep. so vIlaCmatNt piute Csk~ikkesotests peeeb ymlillc, kilool typ boitocoapp JsldIet 1500 Coitokosis ..eta osilpatta tospipot kiitottosicso., tIslati osn couple, olotPtacicce Ps asettatnilec 0000 ishlee doaeteteteoIi

ic WIcle Cktiosesd~1 seen iscitudte Liasal solesb impeoid Kals pneeiSt ~ eeto tokstsitet~k..N,Lb01IIhOrdyies., WINib komosoe I~kb,

Lsikkaa~ksotl0lkoss

Petl..II. - I Psimalst kotiot,,tmipee phtpap esctis teiallpe kiieic opihccI be vd.aNpieet teleolptphoioteitM.is hoidodipo ees

onepetsI -N,,c cpt toidiste onpelsetuntI .lio ik-tanodcTioni, -ainatvauoolIi eoTl-55consep 11Ii hleb clipi, elP INIIIe loPI 00 -oie 10-12 otbbek

1.~b linen.. .. ihs occoats on saeibiv..a Kooks. rmlaoLo Csttik cliitibsoci toosote -aipdineas rimpEotLokI pyotydc. , pd.a .jeipol I d lobes, jsUHMWlPEtp 'I5 imipteto Recoc plooc op ati.os.le.. .ltle oenockptkonhs htonea se sO

s.l..iltselIte is puhtapctps diiibloscecarlinlic Joo naoL-k-bstss epiirLlibsrimpIn I.taogeil poilsesmaho metkle.k

HAITAVCKTUKETJAKOMPRiK~TIOT

II.. Fepei spice pa can mootemcn .lok lityt opeis koheas VAROITICEIA JA VAROTOIIEN0PITEITAcINIltittaibissickihi 2-thloe teLmIlcpi pntesopos stymicecj. licoy IAsei lIhdec JA VA.OTOIMENP TEITA mItl idiJ. I 1c VOROITUKSIA ,I

hekkibi 2. ciilucenctepmisooiotaa acrn, ,Llkohd..sa JAVAROTOIMENPITEITAmoottiti oibiih ~~lo.ikliosene VAROFVUKSIA

,LPlcceoeenittec oe epic melo~ittIoalmoc11miemloeiltty onteassA ROITLUKStAJA.eAOTOMcuoNPtTnEtA pet1kcohic

P0R~.Vtaco1 1 maetL.te.teide. b Lb.IVii 0I PcticcepetieoosIot. Lei.ke vol. aIheilo Imoo piiloeimoi hcm-pvita. I .i.. t -tl~i-tblb~lb

- ooismaIhIt heiipmpe I.I I i .bIdLJI-

I Vdliaikeiosstit.pyop I ei.phIeLcLctotilsh. ,,i .1II i ~ l.ilJhemosc lest.1.icisi,Toiks-0,Lsetiee oib ent ioheamtk iiSmctlk aba patnbon1 psolioca-sCt ioittiec1/01

im.an. .atciafAnnint p-nedi atIIen...... oi nt seds tcueo thepnhttf-tfitl.l.ifetme o ... ihrsett theolintflanantiplet besng nes.AP 0 raph thy cnt~osholtoefoknatnahIdiwipo"tfjetjorttdLIMWP

ADVERS EVENTS AND COMPLICATIONS

ch.ange .. sO the prostheic cIop o te talte to the factor In WARIN'lGS AND PhLGAU~~iDNO.ipoItio fnnt. lste

3T.,FAtjaiott ttetntos tt fe retat-ol o ration:lse In WARNIINGS AllD PREOAIITINS. A0.,Wa or fractrlttepooto et o otre in ltd In ,ARING AND, FI~RFCAU eaed tollte I IONS

7. -tIsereatins t-tolts Illd/a lrplan Iteosnip cause b5 ,etllro, c-rsoI. allrgi tocin, the aouaine or potethplieson, I

or"l,11d~ld.-Altbll cement lttrtepe..atir

1Donaion 2FAetrnrsT T.lsatorrtin hsutrfrsta.wochdhradiittIae tntttricanno

IAcetabt"lape

3.dTteoiIartefaltr.A i dIIlII

EanlyP.aste.etie

2 eoteaatea/odelayed00000 I--'fing

0. Edabannte rdislc"it

wekeing oft he Ilbi,iteoolt:ioetpnoetenoIiotld tarrolon,putoght-beenIrson~ intepeaIoTn...... maoea IIadener

2.Aggraocfio ofpIIIr h psttrln otatrrlha n t i onsder AItoleagt dIrlnlay toretAl1meIatiatt and/on atticd e,, its.D_,i.. ,..ED....II bA -l .

I0.ddeblooto on di.lopetipp

anontrri eIllot Aorger Illo inleedifclts/W inp.-eanI of theeiio. remoial of -T..i Toss andold bon. ems. poitiA I D

caid tIoion. of .eoat, In gacro. eat. bipediad/on obtaining odegoatatony sapprt isaa -tt tIme lost. ar d t ith of if-etIo.

HOW SUPPUtnD Fee-oto stemIb.feeto head.ae-abta cap, het. Gentrilo bato-hip, at id~ioda pcaed, and aplieEd OTbIE.hIp an componentA, E D

com oreil coop.stst gasbpImna, Etepes -ldameAlace eatoicId hntt steilize oinslto dIction b.U-WR maybe1steild w.,ith APOD)Or

teoeino t,.. corec rithanoduatiocen-Indreeterdpa the octet pacag lbel.- Ieato from the peiaausocpd.aIIseIof1 IIic- : afte th

RtNEtNGICLEMItN.

STERI1tZA'ON trtI eaeptetson

oIDoLapelOAL)id MethdCyt TeeSperatr nEpesareTime

ItIsetA, araeter ho paidate totoh1 1lttibAfionNOTE: T1e Idfaca procder mostaecita,,tIsted, ha opynopictp00

th proan and it ibil re.dcbtt. ceytI...i may be I-ondeetd. applicable,accordingtoth specifi tetsotsteetatel 1IIpand.I -PlanEli it

. d UHMWPE

CANNOT 1bor eteattieDo I .otIll- .otp..ecee steiteIIS CAUTItON:Ceacei p̀emera heads pe..-.se edit nenmid cetees teddEtespettf mautetn tees a, gtesle

thes bi paegieppar detestd.

GESRAUCHSANWEISUNGr nmmm WISCteN' BtdseezUSAI heoretdie....s .aIa actde V'eetnt ede die Veneede...t darE, -ies Aet.

GERATEEBESCHAEtBUN. HO)FTITDTSaDTHESE

f Iotl Ik s-aIe oden. K ..t

_waiteiiiarAatbeekopafsace l baieldete ..hire i.Aoiigtoiprohee aeneet biuo deem .-moale HipeOft ec Matc. elemid -tdula.en Fomarkpt oatM

SeI, KceramIbM..aI oder

oslettdig aecU.tedf"e die pa Emote,da toad1 bhcoaGelenkfiAchteat H0hee-enkeooracheeedralbinzetropack arhalbIThInd metclli Poletleyfe ape larshhem~i ttakolangeiht (UHMU

t SELF'CENTE.tN. m HUFTPOTHESE pinetat Cdentrie hatrtaeictsn he"--lhh ide edpaatIeae alte fetlpaaltEetllOp Il en e LiHMOEhinrataoDa..

.mI.tII Durtoee cop fee asdewird.de demiT~ der befDneit- tan PofAethlenencEcrf.I. em den Fe I -tepcedl

endainemesdalorap.Matllhgpf .ie d...KenstotoesbAIcneteestf befhf i mit iEro Deco Femer' HDIkactean lnsdchtete Ha-feItAt-t

rIei.h.tebiden red DbetUf-IMW E-Tsgtlc. aIngeetII wid, t aiomtnederclmts, dar dem.I.AedEdcmece de arrdte

HE Mt H OFTrrPOTHESE Fie H.eoirldt~n bootehtee ttA- nemecohTAand.1-kpccMatall.die -a desb~E-oat cautihen Femerkapee ad Schec.holhon

ANWENDUN....E.ItETE H UFTTIOTALPOOTH E.

don prede ic. EdenHftaeaice hal ftiedor.Erlronkunge bowdl...t..oIenatgeoicthtarrpnento

2.g -ioakllee Nebtot dEs enekph

Ikater.ttah d.c.Fematopteclbzw.-oceeekelhaltes biilngnnoaoteteerHatpetitfetcletto

3.iha~l atlacnerAFeaher .4 P.-~ ..dc..I e phkntrido.itonrFiain Atnos, eiAhrpatk allpasiho keeseacoeo.tpedeyutsaecap

'porte to.edIncrust, beehictaeFemurHdhschat cad di , etall oberlaidEtn Azetabutltm-CP-Kmoetebeittl mI llhoaect botet ie dorc doe kit-ckne -o b~iisloeiece Gewa in die pottee hechichlat

Op pe-tpot iad fariidiaamattAIe F-Itaio

E~berttgcteltwid toAti amnIEnee wob die por- bchichlong am em,Mbie oar Varstttee der Ftatio den fanohis an damw em KnochEneptrteIdiact,

..NaIn-peeset coated Eineatgketpetete od,-zoTee-seetece DKemp deneeten Ibil

Mit her-mi besopicptet pomotcckaftptnoceItied tar diel -etettrIeI Einr1Actioatpblitimot., VORSOCHTtZUR'.IAtON EINER MtT KdEECNtKBESCHICHTETENPROTHESEDASF KEtO KNOCHENEEMENTSERWENDETWNERDEN. Madutt~rhemcehtttf end Aaetaettekempeeeetee Ei DefaupI. -ppaeFetnuakoyfee Mate edenbir-si It -5 It den.Do.ey Feoutchattkampenenteoataedetw-ne., Dos Aoetcaete, mutt

aproneire eweieuls IotItall UifTMWpeAoetbbee- CIEptIIompttente IdeeIIa hetabulu- Cop-Komponeate sac K..aik,A ubernltidet MEtl oder ,0ltkmme ad JHMW~e pan Depep -Ertta srdee dAIedcc tine ceagech sa UTEMW~E,KeamIkI 0cc MetalLmIt

..ltoeodrhAe. . earpa,,lmacho die dete AtiIedeaceeIm.oserd.A --atrdere, ,odlam- FeosrkApfesectpniclr

WA....N : Non Dep., tedullne Feesu..epe eec Depe, Ieereetts.e.n Die.te't'~ e Femnkephes MSIDSzt.

.ELr-CENTEStNG HU~iJFPRTHESE.UND HFMt'HuFTPRTHESEN el-AntainEHifPeoth,,en and Hom,-HiittpAthman sterdParV- ba , Hem-FueohrtplacikI., betlo.Adote HisaaIcacot ott yeeIdag dEr

T.luhhttnllesi , honient Air tolEndet cEldbrAnkegeboat-lObwgeatgzitooheecld. Dieyeo- beiA.

3U.tel epakodtanNekoacdeFantrkobte.~E.diP...adrua enOkeklospatm.32

I 131Ita~r-i-I "10'_oar CIICa s ',inni-ie

Morrnlnlehkk-cusuak

linen FIb l ktonilke ko rmntunen ha Ilormiseo yIlktt-- -cikkakca

kinv Ci oCn (001 klotplk-11toi, IIIkaoj lelncpahe o og lma io-hhor IIrroajojennII, Co,, clol IWko~lCkrlrurcm tIluko., lijalie k Iormirk-aiertl.,toteemnse i.kitoekausta Cikakec

Ii~kore~nrrI4. 401 06 00 ookulaoCekentk nstjT k.1iiunitkseenn kkikmut,c...Irahd iie itf ,,niee., ,, -I- _ ,6 koiyhar~or '~ku,CC kchkkeutomjer Cal Potein felono i loha i'ole Ik k-oon Cal T- ,~ k1i k11i6. Ior.1 ctICr p10c. i-rkk.l...... lke johiojo -ej kau krencjkcctp h ktnntaalk l lnrhen , -l ,,er

mmclnrerlcuetIIno..keikkcun,, . -ikkauknnhijTnaltioja knIlole- iloncolinia~-c jllkn sIjniirnlkklice luj rnkecm OI I IAC alkkrryrrte lelkdtto Ill.-jlkoe -rh~c.1toedu iokio kenkeeriollaiohoianhemtoma

TIM.I IT-hi TAPA , - T- III Rinjluuoorrp... rlno,1 FIoo lokhnnrcaljhekouR C.IrtSelfteig-onn In lon ,l .kanpeirierento ekit I lpkaiaienerejmIttnST- llel -1N4 KnI, firtllknet 1 kenna altr~iI Ionant oeI rjlisohunptro UH-ll kWP.nnei-Ilmiteh eu,t on. -terile jkknnouI.luteeT ikicii c bdho tli nioer eItt iiueoprn Posnplercoen yooyty nptoatkiiOaruolrn

Kil Clli 10cc0000 4CCCrCO.eh~ I k. ,1 -1II ik Iri - . ,,-1k I -- il K .Vair mrtollc,onI o.. naRkoo eckua ohnoteuen 6

iurili irhnt n ompint ye'alioo ewnC.krr onnir HUUTE~lUOPUHISTUS... -. l

uter1.i- cetro m Fyiolnylist roha- iooi erpicinj F~i-tke Lih jirucnuriiio knrerhilp. nt kointi Smirouttin 11 jk

roolttc~oicinknuohecrreseutrrlnijria ~liTrinito 3 lhnkcanahS kkRILOFIiri nlenhiosnth~l ~lk.IP .1l .1. ikli i klJ meoirnirrrilisorrlccrccallerk o tapee r,,,t on Peohetnooi j Iaje -krhieeion ernIII lotion.rooto Ior ... Iohfal area

11 ;I kill~~~ag i.-Ik~~lliLope din KlshteloiHU HdIITS:K-lry li i. ,,uini I.jo .k..i. 0 .. .U.".I 13Ž00 ..U.EloA Kakirr rriu~.loi NtiHoimenitei -eoIeiouu ohinnoot. iiiann kOii Ieton. O nkaet uknlioe Oa

Interpreaio of terms and syboI Ermuteru.ng der Begiff und Sy.,boleSignifclo des tIrIe et syblliAT

'D

l . _______DP_____T

Significato dIMterii e dci siboll

hnterpreain de t6rminos y sfmbolos. l- ~ t'. lnterpretea.i Eplanveio im

dos WermoEl aImblnDWu.I. 6pea .Oh ,IM OuIppA..

Mtra Mateia

Qah Qua-titat

Vierkaring an de ierme en symbolen M~tah'icu Qantit Forkilnrn til symlboler MauiohetCuanhil Ord- och nymbltdklarligr Materal-Ct~idad Kfiytettyjen terie 1omerkklen sel"IdseSt Material Q,,rtjdIde

Mcbrid Kl.ntilt

* -1 1 1 t** -- III., I - - 1I m~un a... m,'Adt'Ih M) e I wa - ___ ;-"- - . t S *tf 7LIe, -th.neichen, Vrrcndecrgen dennn TdIeciritihaaisccndtv sIdnnedrpi FuneIiorcddi

- ncd-nn1hdsIIakacnIarr,1hcl,,i hccpIrcariian , Sel Ietein cui~1 ,IivIir nhdern,idW aiisi finA den tinnanz Cc iatIoIirarrcinnh de t.l a i P.atieiitnm b I lHt ~IririheIIh1 .... ,aortdhen In nchiiier-aer, I ino , Hlulitdlu e ntinerenI IH -iInis nut des Veline i. enoraI DonUadlinde i In-bIdahdigr II PeI, [ ..

en- F iInsc'v lil de-Knoeonere dci,tinlii ncriHO t7 " L1iteciitzecII .. R j,Itci Id, I jIleec i dme I SI"~ D-,I, rIn

.II,neiii enIIii11U iiirdcchninedeDI I Ciediscidi- e I llncVe-nin Illi IIIi CvI III IInnnen Tarihittieieioto je aiitrnjs nor`alere -l III VeI,andliZenand

aeerrnhe liinlliihnIII-Ci li .i u - Geec- ci Gcivseeh' IIII - Arnlnin eIcaieni Annini naI, canneine

UND0VORSICHTSMASSNAHMEN dh, In HemrIllfee,, Ucmmeneach ech-,e tihinderte Ptonn mlItInc nhIchecineboi -i

2I. i ThTon. "oor enan-1aselR ItheI'~nllon 1ldCI1 . D~ld.I.di dh d-h~I

.0 IIIned I ede Facrhednn dhi dIarencei I C. ,i-tar ind lod I, he -Iirino Anotoe vo tiri v,deHri-iiehm ,n,Idc -iDoneId Ik nthicin tin; tam.nlenrId r AII aei

7 ien ioIrIII~ t.nId iet~diesi, fula~l rrdmrdeIAztahI II.neoh hocariar H..etab did Hde.Wneq a edele i Ides ndUrl, o d etccute

angenei--ldie..l...I ~nt ,l diiii, 0b h i~i.-

prako~iniceherEidrdhRnanmindie lanetietige bielni.hen Wirkungendie.er Prike1 eiderbekanet.

* idtpeaenn-Koeeonnnnd.renidck? merde. Se Nimpanaubeocd erehhlnt, dnneegore-Iepleber mon.. dee.

tcen~asntnlmtanatitrecinnn find. Sie munso die gleiche ..SBn eie die entcrnhend.n KepAeId.atI.ne.aiwinenmddie

* "Itnepanad inhoier WoIkeserindel od,doee me~dilziertweIrde. *Fe "cehechennebcnen .ace Oaeit.tit Iii, dk.ierocieckle -iectio des not Beoln.Feedersohat.Sr.I d.eenen.i....

VORSCICN DIe falnereN" Eckeaekaenenban. Stariiee-dinticoi I oddogIIedIcmezeieIdI eic .cheeccericn fer,dIre Elieine, act d Ie bCelN IIon CErneer adl-es.ci Idioce vatirne IInslee fONtich IeItnhen- Riik, daliJ~ Oder -.eapifterear

I.Adinn.Ita m.,Ieln Uheleoihden Panieten

C.Nigneeza 1Crtree..I Cu-. dliae DneonemdItrca.nid

7.AineBiidorce, aecteodn VO6 IHtDeAIIIcladrdnOnnneen.o.aaaocdeeeec dngecicii cnesc ie anlnnocidi iair H7ilnAno inep moto ad c ounc -.2OSC1ICedeoh ,ndrne eeianeoeOfadag doe. i~deresensh i ronc-iressiner-hn-seoleoecrI dentester

.U'd-,..r,.U.NdieioaetIci c ceilDibtstriies ncillnpie hrpo,-tleeeceeeio c dr 3.A,,crrcnlict.IaIIIomieeadon lolaleictelnelnioec

4.domreDecmidte de rnie Ccei,, Faio aennkree F dIaee den imhidneatecVnIIIhnec.Irahoioe SC. -, deT~Umoe ~aieNtIzgeaceacc.~d

Uedm cecadceantceain6.OIenies ok esilKncenlre oal ,olneneeleel.

WENOGOPDOFWTOURDERANCIGHTlOT, DASS FIN HLITORSATZ lt BESIEN MOIZNISCHEN INTERFSSEDES PATIENTOI 1ST UNOD SlC.E SADAZUdNSCHEIDOT.DIESE PROUTHOSO00 E11REMPATIRNTONZD VERWENDFENDER AN CINER DER OFEN AN.EGEBENEN OOKOApcilINGENOLEIDETE"D` GOPJ131G UND AKIV lOT 'ST ES UNEOL deitE, DAdS hER FETREFFONDOPATIENTUBER DIE LIMITATIONENBoo OO[IACTUGCFAHGKIEIT VOPRAIOHTTUUND UR DITIMPLANTATFSAIDNVdERWCNGETENDERONDON GTD FATERIALIEN hUlD BOO dIC. DARIUS ERGENENDONNOTWENBISKEll DE OBEN AUFGELISTETENERKRANKUNGENOZ. STORUNGENSO WETGITOHEDvi EMOGLICH 2 REDUZIREN ODEREOCMINIEEND,AUFGEKLARTWIND. Dan coo~d _aicand v. liceMaaece Jde P.ali NI Bakiehie.1 hEnal.eandecbans SnnrtoMnnoer cren mc amen slice -atiegendon

hotigetI hre Rdik I anddIhdecs ralan ric r Nieietian deitlete, Andci canne Inaned~haetepea tii 1 dee anII cIIaI e di. Pios il ineneccsclrn Kdininee etheno, caboi e- nayVeNat Den ,It~Iddeos eIderdenlmioenncaia Foremen,Icier

LibrruiekrpelicIe v eden TADma en de- za Jde HTOOe..ate ecfinand earAhiiat GeleInheret kareen baIatine, neenane P-oc.i...acIdenaci k~, andVe-sIri ance. itnpiar DieOladtoel -Fnhc , Abrieb IderT ,nOIIIe LebII nencareIe- pId loietineoen Htimlalale, III

.E t AU CHS1N FOR MAT ID Prtoeratie hOR DRERATFURCOLLTOV00hO DEOPERATIONMIT DE. PATIENTONALLO BESONDEASAUrER DE dICe AGE DON CATINETEN AU SWIRKONDON PHYSiNALISDHENUND PSYOHISGHENLIMStTATIDONN AIDOAIPEFTE UINDDESPROSTDUETSSOWMF DOROPERATIO)NBOPECIRlEU.EW~h-on denmdespacire saIn ace oIen 1Delckrlneckior,, -1dIeIsia daroanenpeircden Cameoi aIl- di, L ifntali are ed I neicscnmcn..de.,II- danacttate-enlsamnemaher daNItieI . dlirdisanedesoeeeoneeendrFencercladI , I.DiZedrcfder,0peroA

beceneeneimCm-ickoa diednblino r 1dItc anddanGih aise ec woder101. Nden dieAinict, dc eIene eateceo Di pn.o.e. iaaead prtintJinhcOa i ipotnodosnCiSoraakmcnne nice ads dot ceicandinovl- te -aeoheanboegga_ n demcre enEnrkieeie iairtfoe onmen one.DeCorlcrolerCtZeteesreenode mono~cie richmi.dicrpeI tjo hee lmlEnanjeceehni d-rsbce.Fntmeeh Cannon. Im[ardN in--etiCcera hn slotsd d or, ZenI

ida tanip ceieneFliicoe eitcee Dee neeneiedniOnaimndnanam Ktinseet.Oiaeilcnedne

.'.-neoIIe ibiene rnoctne a egeencr idt Cnisniianhaec Goaice O aomnneema emTilamei dne Idaner Iroc.Abd eNtilrcc acnlit-orali h,,ro...ik.andVt sine can.henceendtiieiieo ,doseIn r 0Ptr T

am Gc.AedreiejIs do&rrocaIceInanq F-IIIII eoeineoe Gnt tedecheNIocc -iII imn innaae mire-111 Fii,,mineoeer aeitoOr aedldiren ed, 010 h. - rlpforo am rd. IkUI1IIIIdienrdnGeain.simnei~icagei , .dcircGra ClIne K ~,l . ~ erilidere fcoin SalneI Sadro. d nete een me-den bin ncrk.1 rahACdL-hnne nichel. cbnnomo die Kemsnelon ,Impolle ceden.CeramiC-Fomarhale aderjnin h andoreI drcl0c ieDeeaectceId... nRiaencrsncnedndoescnicoiceccre KeooDIganId,,do KmsEnic an1ninhtcmhrbr , hir jedoh d ercci Ano.oc-,ndc tdihe.I Onede Iplnaiorheee lleeNiFeaneolo no1i,,toIIII Kec octAddee oanea norlenc Ilt., Knchenpieer oIoe.. e. 0 rmdlnririna een IEaeondutincclmeeIden I b-ne en a dein AonccIh-e,eddoneIFeaca-KonIn CeIcer den si Sia-n ou einreli Dim care -die cne a.Idek~ OoeneiaiMortbonIci IehnpOnorCeitrtdecIndes0 Feeote RNdc oI--.aIIheeF - an i, diFtn-c her IciShI-etee Til nicroneaardoentKem kOshaelnPthcdc jctmTacn cideracideene Incoec Mateiainein

KanaCOichiei eccddianer nneeb- nen rdrenn,,ecczaEcnoncaneerabo oomnde. dorindoridpanahotebneecreerate d.ie~I teragedon donrader boithie IrdeceD. EhIARcciihibcaesoIogedd I.,n OencnU einn Pnteccalcnicpenantca doea co esslieOhcDiNtttdI"on d... 1s ccdStcdctaeboe.micedea etii.ce ceIII idi nedeIIIetcedo. Zc-1NdjulIAcIeieh MmreeCnosi niarord, eat .Idiimlonotaion oasiin. DIn

erc"hem 21Acidoid,Paice eden11 cec. . icr-ntAniecbeRI meCin hinenaPAsirteridrn irticlae ,ke PIeclNnbdinacrn Udon..acEmiedeo ,,FrkislhI -0 CI des~rltpaets sIt na Ca.Ute." do cnnieAreccoelian pIaienterFead deOlnce-Odroc ht

pcoIme-medjoteFok- I or1 rad adorLecindcirpatnntrlo ae i edc dnAteriric8 Aneloctemetnpeeen civTU1 Cacc oar lectiitiId CaniniceceII .ac.hicioate Ion. Delc Cctc IOIhkeen. t. I Vondeer maneenchlcI -I Ieice dieKeoecricc :bnnaeieKntd-hrnm- o on it3eet1 hoe onsndnh rcin

Sterie MFG:ISieIzGP Manufactured By:

Sterile Gas Plasmae Mat Jt EiB Susi, z e

Sterito Gas-Plasma HUrstelle Gre GrUBe,

- .- te,-..A O~~Ebrii'4 pa : rail', ta Il'

Sterl, pLasmagassos Pradotto da: DOLimensiond'mes'o

ENtDOriGas Plasma, E bricado par:... Tam i, tmao

PlasmaN de GN~sEsterI FAbricadoar Tamartho, taman~ho

AUOOTRIPEHLHVPE Acp'ouA CLRIaT?), mtyr'oq. pETC~oiop flpo CIEUDR

Steno"'Rgaslasma FubU-kLOnt Maat, mast

SI. e NN Frotistillt at: orrls storrelsNjslsna~ St."

Ste.i Igaspam Til .rkam: Starlet, slorlek

Kaaeolasall terilisoito VNltsisLNja Koko. koke

O.D. /1I.0. C T PE

COutErDiameter / Inner Diameter Coalt ChOMeC Titaniumr Potyodthylne

Autterar Durchtmeeser / Innare Ducmssr Kbalt Chr,,m Titan P.1,Ieth~tte,

DamL6re externe / imetRe intern ChRGOmeCobalt Titans PoyIhyathtlee

Dametro esterno / DimeUOt~roncm

DidrnEtr Exterior / D ~detroInterior

Cromo COEallo

Cromo Cobalto

Titanic

Titanio ~ Polietil~ee

OP letien

DIArnero. Extern/ Dimetro nteMro Cromo Cobalto, Tittno P. iet I.e.

EiO.rcptlrt 51lLECTpng P EOt.rcptKt 5RIFETPOP Xpoipto KOIOAMtO Trrdvio flOxaUoitiknO,

Buitendi~ameter GbinnendiMamter KoAIlt Chroom titaniLUm P.lyethtleen

UdVednig dIameter / indvendig diMamter Kobal KPRom TitaniumR- P.lyelyeNO

Yttre dirameter InEOdiameKter Kobolt Kron TitaniLUm Polyethylene

Ulkottalk~aisNija/ sitttlkalija K.ObOltIF.oi TiAanIM Potyceeni

MADEIN ~CERAMIC ALUMINA COMPOSITE

MADE IN Ce~ramc Alumina Com~posite

HERGESTELLTIN K... IN AlueiniamoAid'Verbnd

EABRIDUE COUraiIBM aluttameEN Osmpoit

PRODOOTTOIN CeamicLa CsMpssts Elallurmin

HECHOEN Cerannic CoMpuEtotdealtenirt

FABRICADOEM CiRtasica CoaripbIN dealumrina

KATAIKEYASIHEKE KspaU~oix6e EH ETSYTHN anisa

CEFABRIN K,,eramsch Aiumendormposiell

FREMSTILLETIKeram IN Alumitnakomposit

TILLVERKATI er.arlk Alearmipmkon-poeil

VALMISTIJSMAA Kerasanine A[Rrmiiaiok~diyhidiete

FEDERAL LAW RSSESTRICS ITDSALE ORDER

VORSICRTSMASSNAHMF: BESTiMr ASS OFEEPS

CAUTION: (UISA) THIS DEVICE BYORSN THE SFA PHYSICIAN

DIPIIS-REINDESBCHORSE SOM PRODUKTNut M it SEMEiNVERSrANDNiSGINESSR/TED GCE(AUS NCREDENKANN.

ATFOZNTION:CONFORMENMENTALALOIFEDERALE t STOS PRESCtIT CUE PAR UN MEDLCO DESE AtISUNIS. CE DIBBLESItNE PEST ETRE UTILIE N.

SMTENZIONE: FEEDERALE NELIPASA)LlM iA LikVEND PRESIDIO St PAMtE NELA LEGISLAZICONE IVIGENtE iAtDi QUIESTO ESSLUSIVAMENTE USU OTRD DiSN MIEULO

ATENCION:LAIPYFEDERALSE FEE.UT. MPLNEOlinESrE DISPOS iriO SOLOPREDESEH VEND IDO POt UNMEIIIGO0 RALD PRESCERtPFOENMEBICE.

L IM~A HME COS OS EOt RECI tA SEEICA.

SPIODRH:HOMEOSSONA RS E RMiAEi H SOUAtDH NAFINIrHIEtOt E. ARCSAMKE

ArENQAO:A LEIFEDERALICLJAD AVENRASEIrEEDPOSJIDDVS

AKHNomoeEDIATrON TRDDODKERS AREIAMOS01 trH O ENroAH.

DPOELE1 SEE STATEN HLLIEEN OrOP tAOORSCHR VANEEN ARTrS SLRKOCHr.IIN SEVFRFNI MAO SIT PRODUCr DORE it WEROEN,

'OIHSiSTiOGHENHOLD LOVMASET SLUN 51EL.LER Ar [ENLEDETILAMERHIKANSE I EPRODETEI SAILOES PA ORDINEDtNG

SB~RVERUIAIUESSAPRODIIETERFARFEN I LAO SAL/AUAV/ELLERPAORDERAV ANNAN HANFrFEESRALIUSA MNST LACKERE

VAHOISIIS~iISTVALTION IAMASN N I AK/SRI tA SURDi(USA)I.AKIRAJOirSAA IAISTENMYANS ENrOIMESI UTAAARAYHSESTA tFTTAVAKSI

ir EnI s -au t I.. a an a d-m-hl; A t B..e in, g auf niobunkercand Fheraemer saowme acm.sge~d~ardenici dwiem[,osihccicoorcha~ltm die Beijstoocngseinsshrarccncungm cm,or e 0 ~ Gaewchtr beialacgn§mc weI E .1 I11 I, l~ EE.,,rcJfoipasieehjdr, ae,- cch11,1 ,Ccjeco,o,coocIcohehdw,IdEcirlaeht-<I (icacc- corroid~

eh.1 ,ceir iremita iicIhi mehra ieLas erardeniL hoer,.soocaidom Rai mroher cKrc, hce'hi marhoe, ~ wird em~oh~em Cat, i ache,,, C~r'ii,,,,im ciu rece'iiiicm~eo Ko,,ir odhrncee~scoinaaeooaubeoceiien Laaentencr deroulrjhcen pieasier~rcivenoi

d fktndmIolr'ercooeirwaccdo, Impiaccoce. besaordrar abe. rei mschish jed der Traclflicren cueder Lrhaituna der impcaoatotmxat~en ijHlMWoe aoolh amcebecannt jet aind bem ieoor Koenhreccntersueohuncoa Puimii~]o~olaifnaheii viale, hoioiscarmcilrirern conl mu~ do, h,ehe,,conA,,rihen zoouvcerolekhxc,[meRcfdrcoag~.auhdhhmcrmerdeq rd~ hiekinetheBeoriedlur~ des Parenioe,,miiieicihooeiCienWeen

dohen deceaderoucien zu trahlenduirehiassiekemh oder cereRoe~btjeickortreiien leetoeste~litwarden asimoe emspmel Knorhonresermlich i'cc,lst or'ceealo',rm,1,oresIplaarcacs. aioddiescoderandorrccenendmasehhi

9 az ehe~arhenadamiteicuitteitoce~den hann ob sieecat~arhseder po§~oecssiceidund aaeh ob der Patjentahcemessoe behandeitaciod NEBENWIRKUNVEN UND KOMPIKAT.ONEN ce, loloredo, *,ecrdirm die bei dec Hdjiclehrcciplikt heeihch~ecohaui~eniichcNbeacnwirh,,oeo acd Komplihaiioonecaiieamainear~eoeben

am -oepemrr -f*u idooiie prO1hrlielre . die rir:h of1 direr W^hNUNLOCElIIID ©iRIdiCHT2M SNAHMEN ahoecelaenenc hiaktrenheziohee

2. Iorzeicice apace dee K omapon die ,1 li icolo, WARNUGFNcider Locherced procheicah ei. IicI auc UND ©PSIC IRISMAhSNAiiiIMNa aioeIeeebenenl- ie

:. hrmiidurcietraocc des lemarsehaftee. UNdhh~RbIC HTh NIECanheeebeaee Fahlocecdie rich oh a,,, die ,,eter WARNUCIGEN MdhNAH bezieth. Ahricb -h -o eorsdiole ad,, Ereiddcorsf, aktN,Ir,, I-ri ,,khaer,ker. die ,,ih ant auf omeaei rl iNUNi N UN [aOi©RSICHTSMA^SSNAHIOENor oecabereh Cnkce~ren~iaeihace

irdhedabeI-ab, $S feirIIi 0. CeriphheeNerropathien. rice eabhianischeNeroeoaehddiccundhano acyraund oar, ehiurc~iroehm Trcauma~c *f~~ 7 Cnowcbaahcmonen,Osloleocyrd/adc,o r Locklrruhe des ImepilarateOdccirL,odyan cMecaickorrosonch ode, do, aiirlarhe,se Reacjionen

Aonosommicc, odorlaceoZeementleiiehehnyen,Abrioepaoccin Inroperatic

2 peloracioo.Ciacarode, roccctdci Errrec~~hciftes, elerderiic hmacehendmeocegebeneoaloseiee inteornee icdixton 2. Triohoaloecchaktr d. dohodicrc do,Elliealelo ciczum Beipiel derA A- ibiac, a A oraio.IinA

adr, peImaneoolnIeerconsohadd ,ii Ncbtu-aton sodora eauchds Na. ompeoraee .i doeN- lemoralN , e ,cerezeiterail

ii Sebiccacimonode, Disiokocian des l-dheeinks aou9rand dorAcswah leo,,Cardoebias Ka,,lcmcgucctmoed iepiacctaos. i, Carsmtmaoieruncoar Kampeoeo ,,cendad/ode,do Shla,fhilt, dor, uckoloa era mbrseo.urnd f c.iod..ewecs..

7. horid....r. ,ieroarcun,blaeon ita tode, h de Friuho pasteoperatico Phase

I Karod,ooaskhalrihEreranlkcc§oooasehiiheliHchl¥eoncnhroabose, anad Mhohard Lanenoembhiie inlcihi 2. H.a.a.are und/do.rer.oI ee Waadaoiiiu. 3 Pizeuihohueadcoder Aleitcaso-A. hSdaaflj, cole hiciaoatio.

Spdtopostoporatiot Phase C cauceund Mau~akria,,capan eaaiahhtsbeasiaec hocoehrwachu

Troohamloar - Tirrchanborabri hbermacicor [ang ade,unbabsoahtihiccer iin~raeperahioor des

2. emshihmmc~run do, Bearhwerdea ih doe iesiilaoralen bore koocdiroalae,~e Kncc are $prun~eoencen aafrn ie ldoiinhda nediskaroepahndodermedicieaVoearlcag~ondes Coma,, cad Murkeidohioienoce.

AoelahaiamIrahlar ascfracad . B celaelrc he' areairhode,I.Fema- ode, vi, Troaum a o, iordeir a n hscedcr ccrie, Ioceheo ewehos -lo coa Cipdramen, ilr.oporatm.. Aabi aecherer Oseeposo, Knochcrdclekteo -eracscecaneneo, r vena.rlaenon

aoneKoaehenreaarptian 4. Kaecrelsarpioe -r icaPian cad soIhiiile Irplenec boilracerdir zar SehILeh.arun.do, a,,,lLoolae-rrg dos kane.

Ca,,aermackijrrhonekalkano c die zua airer, Eiseohnrhaceroe,. dorknocheunaa dor[aeienkboweciiehkeit aad doe Beawehaacaboreicehe cdhorn

K. Iraumatseoho Arthroco doe mp~acirer aloo Onio air Coicedorntraoporatioen Pcdmtmnioerun§ do, Eclromill wodhroenidoeOperatica. 7. cabiocalioc odor Dmeiokcaiao.

Die Inoidooc ard do, Schwerecradvan Komplikctiaren beie, Ha-loratz id irR dor cro, beI CrocresenaW eeielopararione,h ega ala bei PrmmeocrtoroonZr den hoduicc ea boi do, Woehseleircraion achier $hawieriohcitce aol do, Inoiaiocspiooimec.ngEatlforian§ 000rbiemrro

ekcopera Kneehen acd alter, Kaolhonromonh moni . nid Cixationcic eaten area msecerrun can Kam E r-ei Kneestdzm alloemeicor sind Ian Whoseioperalioeen cine idagere [aporalmooodaer,Bilavrnirat, lclfelionsrisiko. Luncerormbolice ad

Wandihbmaramm, er erwailc..Ihacami .u WIEOELIEPERT Der Femrecialaum, dcl Coecehkophdan dootaboirre hraienSell.Centeirin Hail- arid dir Hoemi.Hcdlltomprenecocnwardene ie STERILER Vorpooaru oroanzlsciorpackt coliolort Alia Molall- aid Keamih-Kompaoaetonwardecnmte,[cleteahiun§ atodlmiojol LiHcW~eoKareponentec kennanrmitteis Gaos-Ciasmaaoe S hluchar slcriiisioriweden. wsiccaadoe, hchiid auf doe daiherodnpoehpaceku~accgebenEresl naehdem dime kaorcekteGrdcc heclimmlism, dollon die Kamponesten cater Bearolcep oclemaicranoptiscerhKauteien are do, herpaekac§ceoammenwordo,. NuatcfurMeltal alomponontec: clean die acedeie bscrhddiocCerpcoekuoc orrrheiocodor die Asepeis doe smienie Implelaltat riohlacwahrlosttisho daireelancat jedoCh raceh Meicare doe Chmroaren noch tar cdo uriapnhciichoi riesaclakzeopalcelismurea dee Gerat car Impansaiolecron9mb der coipendenrAnmoisdreccabe~pa1tcardsteriiicie werdo,. AOSPULENOREINIOUNG StcarteWasaet aoe phypoiaooisaho Kaoheailolsuanc c Zimmoenerperator ore, hinwcirch dos Impiatats oerdseodeenDaa Impialantrl~wsenicalocs aMinaloc cinwoirhen. has pradukt safest crariekic.Dee irepilaltator der Stherilisat iaaniooinsizen STERILISATION (oar tearMetallkomponnnten) Coicsdie Sted lisacciceiaer Mtaelkohcopooehte chficwind. wordoc die loicorerdaParameter, mporlee dhecisie fdr eia Cteriitats-SiorehejhlatsNmoaa lStoeriiir Asurancre Loael BALi oar 10-' vaiidied warden:

Methade Zykluc Temperaute Eitwirkangszoit Darept Cracakaum 1320C t0 Mi uele

HINWEIS: Dir Eicraro dcc vermendeten atriiarionmenoo~ahreaemae caure~ciheedgeestno ocorden hr jar I~riobci keriach. cloidasaulico Pcaedcoaramoler fdr die Sleriiiialicacecdle do, jowoijmcenEinrichcare and die Pcaduhr-700laddllskonfdguratiac ocn in do, cidociet Sleriliaahianseoelanorcnaciremchodacacebmidlore un ahlampoeterorm Pereoral eaiidion cwoice,. um doe Prazec ecasir cri~e Zaarierlas4koitacd one Repcadcaiorbarlreirca ceoldcigoc. Goesundheicscindolnchunrice eilt-rcerilisaieoti hann.fall anmendibar.com~c doe Riehtnijejo do, joawomliooc asrchcotibhr wsr~den. VORSIOHT'Kecomisohe Fomuckdpto.Prothsecor mit Koramikbeochichtacungoen ud Kornoponencen, die aus UHMWPEherogesoellt warden odor dietes onthaltet DURFECNIf~Ckithwieter oontne~lmtwanten. boesKemp oetootn tight cereodat, 'race die ~tterle Verpackung besChadigterelchent.

r n ~~~~~~~MODED'EMPLOI ATTENTION:a oa Ia prescription de ca mat ~*rli.roi fe tdddrale arm~dtalna (USA) auterise etc seals medeclota Ia vents DOESCRITilOP01DUPRODUIT PRIOTHESETOTALEDE HMNCHE to prothdee olale de halaehe eanmposed dneo htig fdmralie ec mectal duno Idle fdmocaialermdulaire en mtlo neaiu td oompcsantsarcerabualirm deac Cd moruaimrci ritra coeda iuHMWPE) door reoereorement md aiiiqro ['MetaieI poerjos en poiyethyiene pado bcar'), ehrramique mc. toac UHMWPE. ercbriide irdia idaoliemont, eat doacode do ia surface oraftieualre t arelio do laroduiG cc rteaplaroemnt

DE HANCHE T M

TM

PROTHESE SELF-C£NTERINGLa cratbwasdo iarceheSo~elfr~terinc ace an insed on LIIHMWPE01aneelart opac~alt hdeispheriquae raneistent en ucc rupale en metai,

donnee retenion on piacticae. qui dojoer dtre atmliede crier Ia cigefdmoralo DoPuyetlca cocomhtlliqae mrodulise, dant le diamotreJ rantreapndracaudiemolne interne Fiaisc de ir prothrdee eilf-Centerintgr purc roimplocroIa Idle toejoldt en eaihdthllrde rai fearmur dcc$ I anhrahcaetlj pahiojie dejla OcorhoeLa pratche~e do coerhe Sellf Centring eatealemoenact u tilado commo semeasent dans ieaarthcaploesiec

ttlsdo haoehe Ioccacroqellaetscremdedare asadacedo suppaci or UHMWpr. do dioadtro jinrdijur caorrespndant or diam~rre eaxtdrmoado iarrerl~emdrallric uetlji$jed Oeratlie OrUHMWPE crest accalorlelo eiji solir$ earnieo~d afatpocedde Sc oernr Iacliani ie raf ec dilate e ecadid i lco~lSepar- dcesseaIc hee roldiaco do la tlte Idmreale maca lair¢. eamsneprendsa tarionaiciriin1e.Lc capalo or modtaloetncailleirleieote on UHMWPE. neooduetijar dcesaiajdr 6aideeecore doe erpalos di eseai cet llqaiiscoldoe ratoliecdo dimension, ilecfiqaoear remOcamaanta

PROTHESEPARTIELLE OE HANCH£ Crc proohdeseparlioeiede haocehco. ompceduntacoce hdfareaie00 mtara ordunoe Idle. eet darede~l raopiareo lahole ct cc Car do fdemurcore do Polbahrpiastiecartiejic. UTILISATIONpREVUE ET INDICATIONS PROTHESE TOTALE OFHAtICHS Lartiroplascie loacai do haraheoa pear hal doapporlec ad patient roe pica grande mabijta et do dieminaonace da~eriocrcoremeiaraot I arherlarior do la hriensdhereedmapoo, laeIorqnalrai precoe ca l reocercffixetminenetdoc eel, rare permcetrleI-impiooteUoncdeSrompeasa

Lclero~uieereiplaaomentrtoraidc la Iarheosheljn dicadedaaa leosarcssioaoole IArhiralaticodoncexrnleceantoloacureus etouhcanOdleaphe al ~adiuto dare anthrase. daco arcrto coattumatinueedune peaiprtlnt$rrhucatoalcde

cc dree dyapaicei acegdritoled1o haeh 2. NdCreeose a¥oalajredec~aro addufma,. 3. CFractre lnaomaliqer do ja t0ce ad dci rot da l~mar 4. Erhoc d'arao precedeartc ehlcur§ie do la harche:reocentitaltar do I'ar ljcciactc, iationha intenrne arliareose, hdeiarthrrpiel~sie anthrapiastie

par ramcplacoemen des acrfacosarliaclajire 0ureinplacerment total do ia racher 5. Cerlalca sC aSc'akylose.

Cempusrets aceedte~nto poreut poi'coeatte Loc campesanta do e lap~otedo tolabdddecodo.herico fametaic a cevterleoat,orodax Ccrrcabotaa®eaaiooleicydiecnecace realaocr~ecrn ,rdraiihqa jMetal-backsa.evr endea pcar Acre atliizes 'arc rimmoc.a fijxaticdooltantoe~rde par Paocdtinlntcriatl dans jlee ce~ementpaodeu,

l ruodier temetareaxrservant pnohdoe arimeatle~ueatormv IAaoometolerfixationrodeila CampesetntccimatctdeLostemposantsdedolaprorednecctaloedderchohhermer Otiqaetes acer earriaelt.oart,fdocaieolaleapaiocicotlodanono "A stliliae riunccemoe prdaepasipu tereseoidn adalemeoct e Composants A ceveroeretcnot p5omatxCImpachor 3K~toJ I scalierLabilefemaraiedeoa "oar trapactbin 0u sereieomoatanicuement" ec tpreps-titreomont non poreux Itiqueerd ear pidoro poal dtre jmplantcee non

GIe I,oen.- ootdl ten nIl do nap do aceoie on dlo bj de had, ne I.eohe -on nnri not 4/I maa .roton en dontoa Otojoo Iat

feo j nIhothoa 000 I 'l of otnh. hoo oppo, ofo i radoohiIe cu eooot O hotoca~d ,igI Ie ndhisoafon Ije I de10.0 hItIto-o . ...ae -kotoohon.Ano -n IIeo ar6 toop, ntohd.moa Idohnatejoljh 000 00 ol to oaioh.toI......I

temtonelohoonloo blood hoaippon endIdoden oneo do ,e aan dl,,-de nofo nooson do, heaII En- 00, nn ole hop, doIl he unoee huto co eando kopplin tanse Id n onthlmooo. Di o toottee de to.,okohap .a hot 00 oh hot

honnjot. I-..Laatootgooo...o..anoonkaptoieaeeoho1hornetoooot teoooaolmoooIoaino-IoIIod 11 pInouz aoat looIoclh ahhhsoIoIIfnah. I-II- finhntohomomoohIo -tld- -oho-oen diooor-doon

ho I,3I ... I .ooheoootoooh-apo~toci , -,, I. dhpodIfoIhotennettoe I .I 1-1,.ldalooonoebeooenhoooohootpotoooh hdaheoeo.oodtoooooiidotd .IRoteIoao oonIhtouzomom IIoa... I Inonhttdonno dIloaioocoontlnplaol.aa..to-o.- oao-lotIo-o otaonoIooohio-ooinIohtIo, koonrnloIdoeoOo. Id - Idfinot'oteooo-oduhooocoopn-itnodaandootn...okottinooon tlotlmpl~ll pomp-noddotootnIoootooo.otdaaJoktahnoIIhho-r-o.odtohohoa.Ftwodlo ooaiooofomotoornooe..,nooot doIll i diq tot loona-kino hotIi.lantoaI 000 do otnpn. 00 o-dodeel I h.otI oat , jat .n .IVennojo todtanaoIoi foloheopoo..a..i

I ,it-to Iotdjoaootooonfotpwiohfoooloto If- d I. I .- .- .. - I- l l 01b,, 0 , 000 ponpIIIfs mpod ooolotnnd,,000 din IdncdIp aoodo o-ntdanot 000l- cnoIltt.1II 000000hotemet kindioth ik.. eaopo

hoteo... .. dooho ophtnohlkon eol/lo cot~ hotoe IIop fdoInod hotoninKpiabti foooto. oooazokot- He .ewoittbnik

-000000..0'..,IIf....

ain.ihnnO . II It -d1d1iOEP I.160 10 .100000ool. tonik IdOaf j do.. I, n~ltp Ifh -oooatoit* onnl do tnoo -. ..Do aoncodtd tokttI.. ololtooot . IItaIozot td t 00000010~l . III ldkf.

to oeIfollladftlhot ziknhd.Io. fo o-, ao otolodt ootoih nonoioo anohwtetao oetgoe htpnn dooonoeoOp-rioo hoo Ol-ltaiodi.- Ta- Itoood-.kmootmodenpotfoaioo...doondoio. gedoo~ftolik Oofoonnth.

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BrJWERKINGEN EN COMP'LICA1fES

oooed foototon 20 nooihoidshro... do fo--f-tor ...0 on00,a- Ido I ttdt W llR0DHUtot I00(ON OI IOODlOZRGSMEIOTRFD101oItooeldo

4. 1 aE. at b,.Ik can ho ondend-o oat polyothyfoon -k0 0-ond not do -odot m.cRODHUW NOON ON 0OO00ROO~TROOLOoorm id. roooo.,

0. it~hoocotoof 1000 ~ ~~~~~~II .natkon.~l I- I0. pnitno oeomorhohot Of 00010 00 ~t petoieltt. hon-0- 0 bki nio zoawenn diolhoplndotI

7. Woo Itoolto .otolo 0,00 othn h-ot Imploth o do o hIoI, alooIoph E od inohnahoooohliaodt-tjo oatf- Ioolr o-o-ntoordooltjos.,

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t 0. - delegirt ooe-holitn 00- do odnpodootooatrcmIIei

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imiotaio emokoso noonononoaiito odnpoo on aotrotirt, ood..E...J S 00 6 L r N 0/106 M010 r -f

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imlontant IodoetdmiioiOiotocoeltprut Iddel tooo.lopcte .Idp -Id00000 .toonm-d -kdeo otnfnte.hen otorrfonnd STErLOA. r orlornikcnd nc ofon onderdelfo I , roIco1. atonirin ic. 0 monoleo ndi b1 donorond. Iodtciot ALltnltlnoodvdol io wooden. o dtoomoootannooaco 0

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-i,-locoKUNNNET oehornk,lrood die InodfI ode If .000ddo orp bckkiootoshdey bOtdci.reI IdN wole Io olcoo ,

ANORDN0NGSBESKROV..EP.SE S

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t somotrod 000 0lmoalOtosnoooron nt~n- ltn knroihulo000 otcddno~to, 00 domte0 0 enroortOi onocoit

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Ii, I*f.S rn- luS.ogt..q. fdludikIplul, rtk n osn UTIUUR~DEClIENT OUWJN. PROHES DECE8MIOUL.m TIO. NE MIRA P.U.RXPER UNE NECOUVEFTI

.t lbo EDeIu oTil eeoc 1- tie t~oo,11,10 doM IT loduleIoo1 oI oI'll eo, onl -c1Tno...dolIlt icc Do.e,. I oponbuloIT dcii Otronrottt

AVE.TISSEMENT: N'Iuilio.. .. .. tiidosl~oceles Dousl. 000 tud oon1e ue s leds lotononios idndlulid.s P., nose d-bIes L. Ohotegs d In DOlTidt. ideotiq.up do Infldid~pnofilotep PROTHESEDE HANCdHE SELF-CENTEINO.lpET PROTHESE PARTIELLEDE HANCHEp

.... 0! I -o romolNPildo~l'ipds 010scind toigotmonh.L etcl.tDiOsti pndiollodoontoel..o -o Lb ADI lcnItfIsoIooToT.1

.dldtoItooWeoooertOIrnddFreor codolnT.TreoLdTiLto. b otbtilibrisntnhoetoidodoII Id.IeTteirtorne.I IbTioArdo 'eidoC inoriht2.I Wcooloodtido,, Inteoct no,podo. ..ttotel~doit -dotoceinlMenoto fne

4 N....enetOieli doT lnpr,ou tIll el. do tooler L~~dIT~l-b-1 ftoth' te sdoel. dotdooconoorojo .1.I~

Ih I., dATlltierot b doromb et no dotetylo.~~pill

ttreeoktottntietlt otodosiint" I. nt~er~doomp~qerr t dl otro .p'- 1010110 poecloR-t ,pecOest setislelenoMTTefeeInr~r lt eTi Ottottnd do fece

nthrop.ostiopblol TITIc ,t~ ho.l~LIOA, _d l WM , u11i d oo11lt-Ceotool"Te .. .dhtto nercho.I-osproMte dohdr 01 tI 'ie fdmote t orie`ie sott o do-irosne edmtoIII tetldosdot bul

oocoitot It ei,.tit 0 diminoot Inddol . .. ...... LeDttiplileticdo d cootl loseioTepeodnoon pot, Innett _oloo domenionooooH.Teioo uootonm.- -- oeosoise.t.....t...._otootloselliot dospoi-p-setic...r....sootsseId selull ntdolodosIopP-1,d. .tIIhIoP.de

I AEilntelocO- tO0L cr00I hoodiocredlo coi doool"oI ,-coo hnoicertiroticoteteid01,,1 testioco, Coon,eheotoo, ITT0.

I3 T... Pot IupdMIIOi,dool ohilotyh M hoPeriotoofionie lidtero oTeO- SoietlmpittiCon doIctet leoetethtcther - ddsob d odrs.. pIes ,d I... WD, .tho titnodo le

`sigtrbilltioddo Iie.Ind-eblithdo

CONT,- I Dic A 0 MSb.1l. .".Id IlT u Loromplnomottttec loopelioldoIehso no--niTl.odbnslesidooloMocts IeIsloo

2 Pete msuir.1- J ii l 00l-idi do001cc toiu oodnotlCitiomotiosisietiIeblIeeeoMoslntn, itciicnrohncleir lI

Iriiet do e dipFeIT Jtcouec qoelitopu V teete leortos sol C ottcoo s doItetoo mitel on Je-o Idos botpeto

4. ti-ciodied bieco oI'ltoleiedo Reset.-11"l11

0001000.prdso pedioled

l.usotlildi .peot1 1301010 to. rhqe ido D. ld. FITA...ldu dolopneeionot. msnloi I ld -- i

NOEIn dhit onpu. d o oPosddillu ntt-idi,.periso,,eT t ecd~ OlocOu pempuldipeie,.bs. Plutien mploorotdelc

peticot ddiehtcostenI.....II4. b. ipd.dli dFl S.lff~do.t bdedstiki-oAtotoreo d trenroltoeho

. dddf.. i i-AVE -iSEMET. rPOCUIN ATENIO-pdp... udud 1bidI"'uMT d1 I..I..i udld1lpbu .dd.Pbl

budhddar ITsto Ajocuiuo di cseotooot quo, uiodos. nos ldoioupIuto otloidloocus on UHMWi too tonos on. zitoc utoidltit~lu ini

*Los t dl.s..orio soot 00 ioc, on nosoohlo, Ill~tqe thuan ttiu osoorsl.-- Bo u losos I

us.11.~ ottioooo cue - d...i. fudlu mosque. donporionn tioiqso en drcicdiquI tonrd.ots btdoid ---u e tpi- d e prisosso ocois

oNLnoatorio idrolonnotssemposoo.,doonaP o.. diooorocustobrioooos Pytmspoh~te Oo tId

....... rt let pib.o.dportioutoe toLas ccittuddo .... nestl pour to meomos, upis D... 0 f

d O odioootjIdamoigs ..IsIs onnoosb.ie.1 'dl- .1 dp ldid .D..qil u

. One oppome. ulAen.dofS4ltcc.'.i iuS~.o~cEsce1 .dpiqosmnolscelspetnooct. eI. ec-odluiran i ild I'dl

*Tolousedi 1.u..to lusepothsutso oeipu ost e rooo dso OdletpsOtooonb.s00 o

IsUs bosoolo.us-DOuAflocir .l

2. oceLmeroeJhl.

ciAT. d lilibilitOPleton lpes

0 ATTENTIONthee erfctos snenio icohToenoso eoblrpl. tordontld s~PPL-ool Ruienie no In I1 00do"tse"

,.-..I . 00 OSIIOI Oteeosonh -oosdioshseo 2.TOnoclsodoi~M. .ittalsm ceodo isnohr plot-QOtl do secIon ess.e. do Ibuteitotnootsmddipemoloegtrnc do-eonie

plottAso (petII oodisbot scorn. Stnri docimmcooWtRst"oott, obe 3AT. IItndorstIs1 ahuolsobdon loonies.citetis

hoieof,erlldooob.EdoromeIot e-dol Ptoths..4.enmetosO ..... .- 1tosoAnndI p~l 1.T-mcedoe,,trootutosdo id-l

0.6 sieeeloicsooe-iood cpetis pmot Ittpo-bld"nIht}

Petnocsiiti Isptooceiqcdosel u~ doII .I 0. RheptioS des IssIslaIn pelresioolJos itoplo to. dsill dobtisd I05c10. 0. AfiopleoITCetro Idnnbipeleo. Icoreco 0,0hv

LORSQUE LP LCIAIRUREN PSTME DUELS, POCTHP5P TOTALE 0O PAPTEELLEDE HANCHE REPRESENTS LA MI LLEUROORTlONc THPOAPEJTIOURE ET DECIDE D UTIL SE. CETLE PROTHOCP PREOPNTANTL UNE DES MALADIPS CITPPP O5PNIL 01107 UN PATIENT CI OcESUS CU SI.OPLE.uENT CR07 UNdPATINT LEUNE El ,CTIP. IL LUI FALI AOSOLUNIENT AOERTIRLE PTILENTDES LltMiTP5 OP RESIOTANCEDcc MATR ILIX TILIOESPOURLA, PROTHESE U POURSA PiIATIONdPT,bDONCDE LA NECESSITP DO DIMNUER DO EASON PIdORTANTP IOIR LES FACTEURS 'OU DOELIM C1I-ESSUSMENTIENNES.I

Mo. isoOrn~to clprll.05 ebsonno-delbtoesnoe dospenig do ,dptr'tad pnt 10mecite Mlocot rotendeeto oooe~iisOmtt pesepreoiotlnnpmritortodscco Coltot pmph .b Os In pi,,thiuo o . Ssodeito, 0 In, ditoit.c do mTniu Adoiseten

Use ectirrito hljeiquo osooie do I PITopinodoonice.c All doe~hteplst00 05ttcersstistn rtolettelot 001 Opho bpeeo doi In hereto Pen dIpP epmotIuprono oVie osnoedot"ilopor, La don6odo vi tosptheooollodoe pempesnnt do he ponetihno do bildnr moor,

4sedt10 dIsInmtIC PiljlosoACsnsos,pe ,lie~n DI . dnlodr nio nedebilepters lo qe I. pids to. Iicoc.. denIciIA p~utt-

MODE D'EMPLOI ENs.. Edoo"pkrsim OVONTLINTEPIENTION, LE CHISUEDIEN DOlT DI CUTOR ASEC [P PATIENT DE TOUTES LPO LIMITES 'PHYSDUES Er MPNTALP5 FARTICULIPEOSAU PATIENTPT OP TOULS PT DO LET L, dcc 00010 del rrLorolosulitnitLEOASOCTS DOLACTEOPEFATOILc FEOThO

Le peso. Pr1epArTtet ot.IN~,onrrncIn OlripeITdiplerttic do poeI cemP.srits do prTet-s do -herheon binotipO do-Ieolpooottp sh IToS leel sbtsuo no cocos do - dolppooloodo esone prot-s do hteoho. Lotilisetietopitisc IDotools Potih`do ho.. `Tnos

mThodooil.poerecot n.O.,y no -co doduomps I1 ecop .,tnteioIoe done, pbs gend. ..p...orc plisi-c DesIDotlocicn titIbo do too ptnnooolso otosrtdoto do. sonneos dofottsnionnnb "Iootsetlt~gct..o.ot proetnsstnOsotnooeeI-~ottelttcnobl

dessisot Do, INTOhern ot dos~ 1u Dopey.o idd do Ioplisoptercplsoo diopbrihi Tc Pe

IIcc porc I P.cIpT dIsoostio dosd l'pliI o cooI -ie 01" intotooreoolI dll" btttplontieAbb Ce....s sostenss melt tetooo ole le.l cot pri-oo n. do p0000 It sboc,sn poo,,'tnoohs en MIntelbloppeoi Los pooonieso deiesDde Eb. soe so blos schos soiurs Ado Timplesthc L.o I-so IdcWCet slope inscO lceoT os'aaTs TODSMteo i -eomposnsttoopcontnoqeoro' dcboon pes OttoT, sei,~ upetls oto pohle c 05 PIc 5crb unosolecIOnto. coospoenst p on noI 00Loc .-

Oce :in tots 05 ldtoo oneo.c.oreoon .do isdsbe., PC eel enceeqoorld roctoc do pretlo A...Iodo mottre eo punls -o - ObulteOC otte d Intin docotesOdoolo oltOtt ndidedosoo. cseoos eepstnnaot. olor otpsdoles pttlolo 0 tlrE E so lnege

so emce.. t tot dIn POl 010P4olse pTec Pentcr In tO. .. ... ..ooIor -In, e, norntiseeot rite oereh in Id0100 P5 d to,oct 1019 Col to.i .. o.

too Lstteoee dunoott eoe ilsob ntdt -obtoL s el da oS- proldtrotIsc ps fole tore tometulI..0,Is o . In oroot In elan l . dcn 10

000 t.tides dno momernI broos peosoe gos Ic eti en dWT implnrs.~ UsdIe Oltio." ro bisc ITT p~ece ec Os pes Itinooticot doe itoP lort peocort procno 1 lot uions,onnbrteOl. I1, pernossodoent,croimdllsrt dole, doti~b dec10 teoctiosoetho dole.priho.TRos duq..osoe IotrtpneOsns pocd.- Imhddn dcteootsteoodnimno doeleerde Tlood' lcpoluld,onossTTretticoo dooeon riLe tomncIS do N-L Cet Ic Icl N itbdilbit,[otonoo -uemmosentepdlebcteimno, noon J coo etleelns do In tenho poet osoAdos etulconoleno do[It. ITcloico. Aent do TOfooooloub,1 sit upticori dolt Ars sohso,-eotsoo udulenotAs dos pottipehoc c l0e ons oedontlloeIseoss. do uloltoido ,ssnhostoono- lotoT IItdeeettnotehnAc elusoleosodndilcnn..iooos-Tooosisoo/oleotteo

4Ain 'd. 11"' j~ sunIltIa a-ia......... "","II-.....: I 'd- . Wtfld h,, q ffl

Pereceatrnnncn belnlmdttecu-etteeatsd.' d clallEInnnnnctm keen, eet,nn o, piere,Cattekdl .a... tenemIodkennl

e na In iddeI n,lpperbetndrnirq rite nfr- Ai In preene,,1 tIknenng nI kneelcoene

Femarskatflnnacctebdloonc, kn-npiettemclle,en11pc-cnter Ide, e,,tAeknm eId Irde,o, Fan denced,, En Io'edknltlcolc ott> mod Inoqeceeern

Ke-aikbekldt tonu1 apaitte Kear ikbek-lonntfemoainantpatoso er Md kere ItIoenntret ih pccnt kdsetj

AEOARSL: ANVENDIMKE KNOGLECE.dENTTIL FIKSERING AR EN KE`AMIKVEKEdD I PROTEE. VMidebr eneol- aooetbu.. ckI... ece En Decoy -rn,I 1lenn it- ene ci kerkt, centbrocoealerenc DiecentOec,,nnkafk-enp,netAcci,o ntttI de1 leokut kle

k I 111,11 ,cenkeln n-ie, doe1~Ildll~Id- on tidyrntpt, ot1mdmtabqkdia kal HWFt i. 2cyken -Il

HOFTEPROTESESELVICENTREREINDE 00 HALV.FtOFEPROTESE

tII.tn.keij... A t--moreanen Heeefeeiantk er indikene r.d-llnnAnIeiattonVdeqndntte Ieqedtittnde: I Cken knnttebA~dd nIfkll,eenku AtenI.,er-lile cor ie IIe neduc-e tIitnnokkeliqneq t,nhace med 2.I-na ldle ,,,totrkndnintnontee der 'l dn,l~edlnen nqtentandide-I retl nternq1i eke

4.MnIndo~ ndirdea col,d ioohiko Ieb

S.ovleererrd CEttencecoeeqoieldrI ccerefq-et en-,lIqodc aereanetIi kec cd natattooetpatik nIod Cenildk hatd Ice. paelinnectarnedb Ienlneqdnf-n emcee -d Cricdcat Itc sand Cretnat enctatt idc, ceadi~delded11 kAlanieh atieste, do, Irantitcntkei .eaceIi.,ti ......t .. ondcce...tt.,n ponontet..,o,oar den dlAncdes IIoenen-n md,en dHMWE ejiade, Idenhar en irdendig diamete, den,cotonden ade-nniarI-.,A -setdte,1diaee dde mea-can At11-eosennee kempie Iecnttiteditore onde tdiardedne., iddien

atet. inidjc idoldnentuele. tid2.~ TIIbern oetrre"IieoqdenC;,Ancell iren knotnareeee,IE Cat.1eanmIaatikdcc, -emptekefl-leecttireaectaecii f. vundenen c Oiek-ettlecatiK amptot el. 1iec~~d~ Can anenaciein cetne petleete. els iAlc indkae.iesn nonh a. Aepeejdr

Itonbun.11.,1det med pat iertee aider,eq erodedJandorCa econneede kiae tI aeieltet states1 ec hotteciedsaiacticq (cc RAtctIttADAE..SLEESVIE FO.R Dettellf~l. -d dom patientIn OadrkttcIled ace1Car heem dot atE.tG~tHEDSt5EGLERI teatel .eknb Ed. enieice.l

KOW.lRtDtKATIONER Fe~iaedetIistatdeer krni,,l 1ditntine. eert-Ir k-,,epiorotie Oat, Oatleenttetne:

4Cd.Oaret OtterPeactaeoqd-ma1. lan akeh-r paeeiak t1 .i absemlr,Itetd-d acetasei meIll eeeedqeit pnttroit acoabaliCaiotneitcntapacie Iilead aeaaa.

.iarteAtdoalA dle cit tetrd Ideudetlke,aetdineJctae, at den raanIqocoaecnsmnpsce aidiII ...t aetad tar

7. Kercereneato kanerairndiecr-oi eaoo- u - MWPE-oap ellfdil ller l.PFctrdee napf.-erd to~Iednlebtbtindtia a8oaoeRxPceede ideIqeakltd-- or diabetsikee bisec tassat cdamen IArtIndikaie.,Laqe, Aet iidettid otteaia rird-n em,denArtIlndl.ieatdtreeCteeatiqpccalldldl~l~~, I d opt mcdat-ni diabete pAarad at aqet tIi tanI. knenpiikatarr steam intetio.laa-

ADVARSLEREd FOR5IGItOHEDSRECLER ADVARSEL,

sine, at et-riumcbitinaiRodeZtreenta-ksgtorpsduooror on forhotdscis ttttomacad, paRVIteto,n6 VAdo n Vootecommo meVtHMWV.PE tndo parnkItetubsqint Do bid.e do einmisk c, prkttntokoera~nger.., octbuu-ep, lactate,, don sainted

E*VHsttteprcVr.e.e.nIe.ccco,mhidrtg"got Stcoe. in,pItacoSico ... thesbkadiet ud, tendot how udklete mik-oskopserit, sam hoe sIr sIt snos.

* ,Ascendotnd proropr.cosI nIt pr-sesorsatt Provepre.oce bar take sainte toed kmon Vod,or borteatnel .tp1 msc imtasetg.Pevprsoe hsssanmokoegrVtonsVIetse doIis .s . kmnqpcnncr do, sktisntnee...I VAed

*Fmurnoteerrtt a gd eclt Cr taia tod at -ki-hleprstottosV. atdotcmteso..- V.r1.tegornpasetn ADVARSEL:Falterdetiteede, enniti oile.lldrAiAncmotttaderde bldestr~deatedsc totlelkat- bedaseIna do Car t ill ketmieae

2. Fpak rbede. 3.AtMlo atrtsdett..Adoa

d. Har-da Ictaitotcseeau

I. a,,ddsiqe it tat.II

7. An1driiqerdockden.I-R. MAM1-i.

ketisntedfti.ek., diRcacesImelit, immanocapprene11-etrI dteap, iactttaplien,3.Cr- s 00cr--qonenIleI-.Ieteroktectktiee

7. Medtad o.AttrEnpani. der ear, ndoconodc, tIlaeat kne-alotc lI as erderasatte den..actaal.r ca-ePlid c kMpie

C. Vm'oaeckiarttririrpattomIer ote nlte,.tfldhid

RURUPENAFOR. ATHOFTEERSTANINGFANAK ER BEtDEOTEMEDICINKE AEEI5JATVlV. G ESLUTA AT ANDVENDE PAPROTESEFIPATIENTER.DE HARNOGLEAROVFN~sTAENDETILSTANDEELEERER UNG O0 AKTIV,EA ERDUt tVOTtGT,AT PATtENTEN INFORMERES OM DE BEClAeAiN0RSBOGRdESteGR tOM DE ANVlENRTE MATERIALENHAP,SAMEOM FIKSERINO 00 BEHCOVETFORVAFSENTLIOT AT REDUCEREELLERELIMINEAENOttEN At, OENCTAENDtE TtLOANE. Faietntonck Iitaeiko etententeree tedl n. . aettardtiIF oI ilitsetbhad Iir eat1 c-dee hotnrttee dIl.1 .i I.ll.d eIddIcqenedidentatEtytrtc, dA.. ar. -oieesIr en edeerdItadt It at foi er .. Cartotinke trebrdois estero -eratiane tartar~R,

INFORMATtOEN. .D..RENDEANVENDEL.E

SeAL DROFrEALLE FYSISKE00 OPERATtOPIEN KtRtJREGEJ MENSTLEtEGR.ONSNtNOERICOI-IOLD TtL PATtENTENSAMT ALEC ASPCETERVED00 PROTESENMED PATIENTEN POROPEMTiNE Dere cmatebt Irktder b.1eqrccicc to iditeCencetcco eted -oEetatrines-in Rh.-e at tMte kiete,e iectnckideeft., ipceirnncad Cersor,c beasn-eot ailolitet a.rodotd atcol es vastt.

par~imair eta imr~itccisa atPreeperanie - Id kirutaicktc1kn Visftnatetsariackenenntr.c saa cder CItatk tearc, Edon,ecesoemI-ndtitvn at scrc hatepste.. Kitrdln seattrac istdaherd ktIekalkb cii Ctertc steci Ike ,ientatRinactcettie,

tardeenaq- m M-do md, Creneotielthd- rnfatr.EbIRoNeat-e l. kocidrCa sentderirdacns sor klnik Ketsk c-rdeceg, onsaOrep-racesreceoId, . kitqik dcctIidsateotn jeti.O B1 ra kiCitraokdneeenscatpact irldkenteAtaa,,, -a nor eq cle, eerie Car clot-c fra DE.to

ctrEt-oenedresdII -d eb~ dettaeiaMeaeebsentepraaeteapidraeepoecaignt.cn1l-f,.ld i.I 1.- paaedeetorrenso ierptaoB.cskt,ttdo eim~d.R.irAorkc btieoA rttCepettn lo nrph, tg rCtrttipatcng ecnaateckec apnnt

itancceode.astphrestCc~leo e betot cch~d enen t akoensitri, iocCr skdeCabr 'en toniee. c at kadn n d itid.liaictctecon didt entatrekiok-e lorcN-ere.M.e,, aren ...emnnaesc totrec te t.IMareqiecpbn

Dtreeei.VeeosFreAmediegem.r Ieeta,cacbeio at, temccattec k-enteLirar atdea Mlercidet Cete.C thanen Dek o Can Foe. ano l - trdn, ecotarde

odeteceonanceeonelietceekniaeermetet tenukoae q tmoket Et iee eebeetnedne-dci cootpaten bT t te koneIikakE.-tcmtac ketomet. aneeimd kdiasactIeradiesedn d-er attloe Ien.l

IVddorcdae e ttba totsdi Otncnd seen ,noetoeren 1 . ,ttooipasattlocetid.-emc- atds emnsaf p acneiara, btcttne Pd. den prt~and-ale

,,P IRhr necasittio ecis1t emnsrct-cdncieecpaeasenttdtedt

,doter teae cstetoeaeeteacdekc tar nititIa-atce' 1 iee.FenocIovcOlteacharnere nnodr i kescpcncn pI., kemolo Catnenctatri ken dot

*S.,. LSIbfhIWLU''""""

Ut..~~ss~t~sdl p.te.. desnetIdpi- ,ts .1I tddeo.-ssefte'stPest'slteemettm"xsttsLantsasostddtltdlntdc

[acuel suiveel,, disetivo- ha'bitvo ll' Is Phase 1.pstPodtsl-ir's.-I'I,

bcIe, P' d'ane.bPaIe dI!I Itt' Psatec'iviejsln'OcL loP.setsetao d'ctio sems ' htospsel od odc

d,_hPxttsVtot Iell dohfixtn safa In UHIIF di, IlL odossplhAtqleefa' 5tat,pudiOtt1CO l'itplt I Ido desnuIs f, d I,,n

P.t, onendppit eee en hO chsAents0 Jv'll cine1 doe ,nosetieais 'sidisrapiceec par xemteden asses dottcvepan-Po,

ETCOMPLICATIONSIFCETSINDPESIRABC.CS

IDedemssdoIa pvthee.snaeo asaeets, mesien1 AVER'IS~pMENTSSTPRECAU'PlONS.-O dIonsli Istbtia one'ssl haodi tiqe vs pstpstt Plb-ast' as tctan cntsI-dat

xvi ixlpsstd,P S~55/CIIAUTIONSUtanstelle ls pre.Pay Latifdos 'shtius, nx assni

3 - 1Patado taill cE rio[a tine xoetal. -acen hoe. ILLntP.llan stind dt atbis hVRI~I EMENTPST PRECAUTIONS. seevest tdbau Alo dens,hatesniqa' ORIPSSMSN'SS CT

4. sd5 vsIIIsat,' l...rsP..ss Pv polpetpl.ve aahlPsesec'stss

dxv~Phttide dotisoI acres.

3. P t-t.FsattctndaesecsuId 4.LtOsIvnaaoaliteantds ilisas alstasattisoe-l .I p.LxsIvttmI., eneaien iitt Its ttstl blsjerx eitisl

oI epedc t acan ooso oI til cd apsiaale capsens a5.vbcvtsnxatais- d 'ticais

3. PrtamxtnolsaelIlestse. x IIs.ties. ~

Ia. ha saIthlasll P--lveatiet

hosirdnttadclat occesi.Ic Sc -d'esnt-'soflbise's rest e5spatt Sd -55AsIdesdtrp-bnt's Ia el it..'sa dns

an'I50I0000d2 Phsitedeta nstnutinait vsneodsI c dct.ltttl decOgrvtiesd ue recreat Oxtectra

den1--ses donleoosn Pha dnicnnll'se v,.[di ,llrtIcc an_' de f1reu c14 den .i

csdsAlten d'ut edn's, d anomale I Ipo Phituna id lanthis, slsoc pIep'Ilelosleoposscos,, essouso Pann chivesli dun all dos

-do I'dsliadluniclitpeialiulit noodvisd sn' diesisufist d' ha meiitieI. IChlptip.ties.p seipsie poaan

I7. Salrlveafixnon Insa lid's.,Id Ifidl d-.

CONDTI'ONNEM NT

itiat tesitr eahid. I sII. d~letenitt PIa tille-balsPil seltI Ptu.,Ilos sci, do ea cm, en t allso d'anpsi et soleso aprn et'

Ott et ntoiis axaIcn -. ~b. I Is cIMPiraien pea' l'ciiste pseoldiepesiffil dIt l tInp e insslcttti, cxlpteinesalitsucefchspt

YA . lidn .iLI's CttpIMtafnl

RINC AEVCNET7rO .1eh ,implat L.isse ItrPhiP Piltdats cv mehns ~i~l

ULin, do h'u ocdv P, .amplvIcesIq' dt"'sstbis past imm

STERILtIATtON('Mpc.a..... en Iiiiht scuteteseet ci ens 6s6 tdid. peasP metaillhi-a ost n6cesec..e.i ost ceihid

encasesas heesydo ssIllt i SAL)Lx Id' ' li usc tosthlicaioden -,npeststs 5 A d'ntillcx henPamhssosdsaleute.,

Tt--ddetup'sut

velce pour chance ailOP.oIIstlisus is et cot h-iantiot Ptadv-tPiatse patsIllpsonn psasdant Is retatie et l'c~iet p's de

prac~d.s, o stPi .ieIssp bt, poxpedantosa dlasiil of so nPsvdldacPiiO SINbeei-, anI's tslisePie fles pea Ott' psiI'ahe ealtPCcirI

At-TINTION he's.t1tes fletscn'...... ildtsee'q, lee-Ndd .t'..elstee dseitdIqu 's' teAnoPasoet-l ...... an da UHMWPEp'osAes NE DOIVEINT PA C'''s'''shshh N's pasehl' SItotehaleg .st6rtl comet'sabes

PER LUSOdERM"MM ~~~~~ISTRUZIONI ....rAlmt' haecetlt di oeeopreeldic ..EontaInasle. Itadi

DESCRIZIONE ECLPRODO0tO PROTEStTOTALEDASOCA

AIItENSIONE:IdhL'sahstatitseeF'sde's Ic io..t's '..IiUS

lt metaihe, vppcseccrPepl'stttttmeta l-cap Icetile ,ePlld.IIInIestd inlP.pihi lose ad sitiAitt pes me1ecehatIUOtWPIQ a in :-amcEL

t PROTEStD'ANCA .ELF-CENTERIN. '

Cuo pssfo , ca JALaptsto it dane Self CIIoos' patlo a' .nc LvccsinattxI .-mPanId as us catiteI.motaltIc cc' ient It UhtdtdPCsen

un'sllxdi li-ncasiotn plstcs ttet ini.it coils-ehdiaoIel ttudol, cei d.l. [eoenst seov di ssttscptasci .I.L .. Do dii diaetta pet ispodditOci diPAmPot.teitttn d'sllien

di .et aiiaat tar-IPis tfo loanl 'Scent miedat in snIetdlils . lhap

Lapr.tosi Setf.Cntit' I posh tooasi-sa hal.te d'atts, soactc'stsnfidtP reliotiloro. I'np indipa-.laattIc'

PROTEIt PAZiAllE DANCA Luprtei IpEtrPia a' `ncuenom asPx osatmrt. s'tedi-tipsnl III pmps ..aPo di ceseitaiP Isttet' I poli Pl femotpost stlon

IND.ICAZON PER L'UE. PROTE-t TOTAO P'AN.A

ldihata sci pantdi

3.Iettsuaics spate dollset- diplio c[rcts

I It adlo-epi. I -ietsvct art~ilfaelidscoen' iIllos stsdos, otteplastiP.eitisenaiei di p:e9tens Phinatais pmdtes.Icd-ca ci.

S. tu-iststots Id-iascItiast I I I- 1.P, I-.ediI 1 . dII .I~i . IE .P -

Cotepecet met as's Pe'scc'sa",P,.h.ttt_ IPI I- 'seeneenI

hsindiatPotl'alon ...m'snte.nehI qcatts 'P.,clnLsoc'tsslottee~tl-cp ssieeimetpteea'xest

Iomp 'seei. . Ietete-itxe. 0 ptses-P.,tI'sfezat,...s.t. t-tetll P050'

ATTEN.IONE:PER LA 'sISSAZIONEDI UN. PeOTESI RIVESTITAIN CERANIICANON UCAPE CEMENTO. EdSE.. 3's

Test's i tredtta's'snts'P-s'eli .coA~bPtonlt'te''st LI 5est fillmetal in -etahlc . iI tonai-ca Cepe dEe .. -tleut-o dP t.IlL'lpOb.O dPe' OseetOscsita t" eset ass 'st-u tledsnl

a-. - -*-, .. A-,- -

I ill o tne nhtlo hgada kendlpoinnnnsrn imelanllect leveld Corr mednees nid P,. grplnstjnenop I~ ,,IWdnrlpeI n red oel evs t ane TIdhe-.. II a h r sftnien taes A-Pnaipadno or iesmdh tilien radipainO tc ..InIskfohno 1, den Ce neiqaIId anienten,Pp/es do osero-s naorkorkonataiooenemPsniPersvee IdInrfesenol'..neootp.onle ondinK.M isatanspsiin- Ssalds mdinrnjKvenIo e t lm, md onsain"ele nhrsjo

patte-nnenfod ret hetltnndlinp111,j ent h E55ifRl iOE 0 OMLKAIO

[no ont biirknm. Ihm eerolatj osate-dlmenelie o-pI llsIatjsneooed ... hdd ild Pl1 nonotmosenonnneee.nvdn orlrieen aeoe dnC

FOP,lII n P hetl.....eHF-1 nn n edS annrde DAPEP0

I--REllr~E

Id 0 IC hP -dlIE,0OR E mn hdiallvve, eokisn ,I .- I.d, - -- l - fIIif 11

1 nthidklan nennornein I2. iFmrelmsetnnmetreni

p 'ovn ilr oo rtsCal pare"de n vnds atsc. Pint fikserina.,

a fnolantevk.noalebend I ,ld~d P,. d d,,~P10Ersnivel"`toen bl Idhofes laiac aluanenp I Idrao-i - r-~idlo eGtepermanen lle.lmo-d-neeed nelne aaalnelniaenlpeeaer

Pellecorall - knd-cea

I.Orioosikolm lomlonne'lsieeraooanon h noeonpdalmonanIAenbolili AmIIInolo efacet. .,.11,b-,,byodlle2 ". II "cnanen ton...... o p

opeleneaelmn sampler.il

7. Sollol Onolionele lssan Kanoi atioeardnedAnn I'I noahdspnd red Colnon f.. k hei.k plrorll- aaend ap11k

., ti n an sane d el naceere - seI ano.. d.. rac.,Ioner

k oIiCM. osan rocennca knen op/ellendIIat sp/ - dkln .lalIn Saiq.e -an deekismonatIscrm Crelosett.ainfololiaes1ikoIl patrenyre ore bo.,los an hteeencaca ndl

locl.ne svaraistti. b.indl, nAeniseanprocdarer . f.AdD iP~'-,.,hr,,,,dd

SKVORDNLENGRESDENG Fonoreaf.emolople aelarlm~opsft- q hloolekapolaeeeer ndateae enelomonoanreenso soleene SERI 1.Adareta

as Mnoslt.pan lae fcrle es.ddo ielanleppi.aeal~Se W- ea dennoerreopseiio Eska daonccsem ei e

Berastaletsandde str nmlem dnaar lte fpiooa d Inalnore0 Ii ~ ID h ......nd epic nede. m A lrlancoc.ct TaClad cnenn enera.nana-olnrn klal Se imp lanttaofenf norl~l,.iaeonp .1..1hd d hd llI .I Ill~d dI,

lih~id~dlid.1"I -P Al h 0k MeAEE:Kladei D - hldesCab,. Terelpenac f- (i.5PMElccpeeicianeej1dd EMKiE hiihehPK.P.. .. hPilki-on .oo 3200I....11d. 1 Pibdkb1

Bdome• il teiianespnearcs aehe eaRtnUcKhS onados.AsNnVannIcsSdNIsoiNsGtpra~nss nOdrB/Selascndii-kaoenoefca.nasiond fnocl persan- a er..anmkt1..- [A. ek ctnlisk fr lPorfica 1. Mneno rsaeaossrde

0DF.NT.N' SRUKSAVISNI 08SfAI-h`kanAk dlgPcnbidan ledarsdd nslicc- ,,d Od'neccl eceec Inane iken e.Illen.fiaai nnidee. . ,.- 1 d-Z.ESKRIVING d" ..... DNiNGARNA d -II~d bt. Ph~lIIII. .d k6 - Id

En Ioenoe rods- Csl or ea -da,,ddthe acninafie- hli,,de cItfmrllhli hi hlcskal n macal enM.od Elid omrlk- no reelatidoPile

Erh.rvrontenaraosodOnsO fnvardes lilsammans mo -ePonlIIIoal a h erIIfseac ireadol-ro on ldeal oreea P-Kaee iareeeInAetn n e inrlco nr ec plateiate ild ncDl o nrn o eCOs. D s Cn C m rneo n h d c n o ekae p n nNsaaspdonN ilar edeNDgI" edenionisda otes mreorne ealcaec

oOhnnsen raSGondTnIONWE m n

alikonal reehdspan ored ', .n.. Ae ErnhCraae ,epadea CeIeasO.nanSOdon-o, lide hoer dn mdIhna katn ndd;dali amodblkeIdte lhrliba tcllsina-sW.neia,-.IdltflalC d lenla . Cs pp daretto lashordenlreA,1 -enaeHM PEieoacsen.. Taadaeo seaonterassna

taeeIccanofnp hlanI AVSSGAVANNINPINDP.iKMIONER

TOTAL.bHOf PPROTES kf I, h b ,.dA .IhA ~dPd dPd I~.hf, I. i II.Tot-al ehetnlosit sons ,~ alt1miekahsmancaare oraIna panosee - -,d:P N,,iPct nersonfC esdt okdada CIl /eri . PGnirneli maca f.....ba no ,dInlason ndjb- n-larc ranicene modd. heI I Coas oa olnatiai.loo i hjnes ~d

0.hkil-iefal aoank -11 A.on ,-Paneeenlkeb. epeeccelenkeeopecebel.oic

ed...e bIstaniaPsnosaldl lemoe Cf- ke- soCacoebtep Ca ne.mealsahel ,mane-n idiena to-asndlenott Oflansaenhlspeomafid AtsIN k oANad oTea inU Ii AoandenENpoedan ienaelrtrcmnea ronntakl feltEdenE porosa. belhnninae td.Nkth.ecrieoee nobemrtese n . CEPesnteadi k ocepenaccer"11I P.kfP11,coersnaloac loeaonalalamee dP fl . I I l l ~ 1b I~.dk - iIA l 1lrenlt l'EndeccIonaenadilsmdooIII.nsersr~inoi raaenasleornoeadamo, Id iaenenIItKecepocIIIeIInseedee-pec beldccic c lc nedpcecA neenalgF-enoral H~toespoeoINeed GorA.f macetaP ik- CeaoiP II Esattt~inrasahh,in ele ae kden medIotes-- ndikns . MckNGasInores.cAnnnrol e med1hen.k~orerNt. Pl - ii.I r k... M . P...Ikh.0 kAIKE cce-oEcNadEcorNonalePcnenccn. D. dmiksetan O leresslakfncpntose cash:. I tera for te -diin inae sereen.I. l f-1, - kd,. I ihd . . fV1IWARNIN-1 -lbb-ANDNEC ,BENCiMENT Ft iXERINl -hEN KERAM.1iKSlGdi IdCOTESMedaliceId I lsae s saneekgpnne

kerare1P 1h,ajnredolar Wonlela- nln n h Sn,nd-nPAnoe CneOb~I en eeoese-hemeret r, eos.Cotbas eotnttsmdonvoodeP. lasoeslateo en~hI aln -ellla LIdM,krare-nC ill id, ed alc reaIelllakel seaIarsdretl-ki,U Oeliensinre diamtlhWO-t sk9aaaa o cedneosC o nooaanrheklnse e eads

ATTENSIONE: stli dsro dlo femolidIoe onacitnnDpp La dimeniatie canto d'lt teISt Iorniaea `lDVC noee.isuade shn iimnio d.l caIno delii sILI Icisa

so et de

PROTES I SrC."" 0"iIPAR"i LPAC fII~ otoloodIonnII CerteinloeonnnIlotioolaIndlndtI.... ..... t netlo"toatnndtl~ anatl~~jltlo~ldlnnaoti

dodjlaoetted'n,00, Idn'i eooe.duijneletndo c nlllrotntcet1 ene ol.Lattoozoe

,,,atadidI. *oaedel Inacoo non ,un e1-eo nodollol0 tositat iadoaataene o oojabeIIna,,O- intern,,I di,.llbo delOcoa

ottlooEltnlanlc diOttsr ooaltdIicnecolcol, e nrat Ii1

nte' tents l Atna 10,Ea ,InndisiInooilojandeA .acal01,0did d"Ineatoo no oetodla ai ano L, I LIdillo.

Lcate,InonIroa ,a IL lano n-

daba alltna IIpe is EnlaeII do;r nodaain olttojno delr.jnlcjioe ~ si- paIenttII LapoeidnaSll-Ceetain leoe learn Elmorl, n'plar InnInd 1I 11 s oairatrpiaotcs 1001 'tor Incd

a,oritta molit dlnngia -id

noapnnt to . e- ns,d n ad Alannatro ,lno,toIiaiaei i ononletL antenna. aotl in mell ,,tiliaaa.LsapedLci 'di FMVO er - Ie

alcetit dc p"ieI.on A tolmt. Iood ittioitd ad no, ,ctAeanaot0010 nlno,a -1tl,aetnAeVEATENZEEPRIECAJiO~iiEI loan500, - "00000 AdinitO a010 0100aieoii.ntisii

nnoti, Iallsnnon, 0 noon, It, 1 '1cno, Ietallzon I nani' fletl OsA L

II deI I0l00I.dellsct nd. 101.1 L.stoll A colnpodsm Laptttd dL m,gIatsnnnanin nnIia'.,i delhi aIta

cdd`T1iNID A~iZiONi

I isi.n tr1itomodd Ill datoiLItonnieotoen tecnt -sosI2.nodita di tenootoi moaiarn altnpl onn"d I Ldeido al lina

,00011 di onnoparoniL. dci ahiranIja.nnnetb. . ilnne e ataten 0 sil conct.onioiid,1 di sea fttti dI. neare eIn sil, L,-n dl adaat sappoenaon-oaIInIacna;l

.:.. aI,.sli..tIOinalaltt dI. oll pesr- .0-I,uoIi . ii ni~c

Elml do Pagan;A 0.adnasi di Onra o 0. onLoeroni arisi Ip-dAaogosnaIn deiisnasoni, caIeredrmaI an Irr Ide ntcs -eipaitna qaioIsII nonic den annaciaden ag .

aEgoiiopoo Ia pil pcisie.IAId1II d II.-~li ,LLIICIILLWEII I at-einciaaa0ieiioe0., ,aicatc incr-nc didaoonnri ecn insiatinieoaieoi-eni.innaococo soaitodo

L010: dlioa Idatatle coo nottIcdioiacAlsln .i iicoe nam nattoolelnie. 1 dIop idcoasideatod da nasaIl at eao ala am

AIWERTENZIEE PRIECAUZIl

ooIjciaiqu.d.. lln coo is ase Aiolabiiel binUHMWPE-O lait.Elde jn.....nilisgsnh oi di.. coai.I

n coo ghioffalb diqoncsldesisisimitnits. oSPceion- chlnc I pai~inia...I, ,a.... Ian Oosii a lngoOcintn psenisl. * limpIaIiocompoen di peoca di pre.daa dios 0 Pa.. di dillinti Iiansi pealSici no deronomese uilsh iniinno *Nan Ijuuijzzro ioei dnc osiolcedoc ceo a.-Iecz cirponbe ae ~icEoscoii.Iuin danni Easl di

pselaec oh idiitint dnidiinnlsn non d.Ia..n ee aaIdil cninisni doelinal

sIlpai poneson doo. d.11. st.... mIl, deaSassCilfO.I.Mi idi. I. 'I.Eponic cannnrni *Uhihiaca seil sf5 crab di prorAsInIi di ...nieiio ie po-a .. I ... can rIs

L.ePeon.. e..o.e

Il~pedn*.NoaIoraecdinadiica . nicund,., Iuf. pe greile Indiccazion

di ...... e aId Innosl I9500 a oic di ,adid-inrismon. in paiiail neii cclgi dl eIcIon., per siiaggioro o cooieci is *L qtsid-MSW-- dooooearidnatsaiclio peosimn doiia do~lle lecosn OsuAre lopparint

1.`O`esi-donoorsnposoonceaio Par.Eoipsioeeslosilospd

did mnid.L5. nicot IaI, i A

.TrnnrI I di oslic". IL"i 0..inoim"ooIcoieeod. AlLL-l1d~

7.AbeltpdiiabLli t AENiNisI pi"enodI nget ait hsn.00100ssnain.tnea nioergiomeea srssbn ei ri

enann I...o.;A . ... Ld p'"

dIoEteme.1iiiAh AcsisarieeIIIelILpIi, MIlnllasnpcsio. I. - L.l-MIp 1)

INO meSolo.poiliea.D.E ACoiasiiEeL-.. 51UCSTisAPROliESicel U.eAa!EnizTzon noo.1 donESMnId U. l AOOP ESL

DiPQROTLPN1ELCA AlRUG ACC LAOOiUONOEL ANCA PC DLIRES MTERAPP N .,JCA IN GUI IL LRTIEN 006NE LAM MI OPODNEC

IOOPEGAT Di RIDURRC NO.hOOLMSNTE001 ELIMIPLAELAR EALIZZAT ao OLOUELLI LERAI000 pOAE IONEEDELILANC.EOIT CONDiZiONEATnEA.A

Allidd fI-iooccoo . icersno passanoll II al -aiimntPoenn -td -0H51100 15 L, llI.to.i... Asat. eeoia mLesId 0000I c.n ... bill00 chsae.I I mcln

.rtsrisica...o naoiae delIs protes d Loatn00 La d..... Isenlo pet I0 ro ... l.l

iNFDRMU.ZIONIPER.US

IL CFIRLIRDD. nova ALLA CHIRURGIA . NONCI DOV ILLUSTRARE 01 1

PRIMADELLONTEROO0NTOO SPEGdAREAL PAZENTC TUTTE La IMPL1CAONi FSiCAlc E PiCIOLOGiCHE RELATIVO 0001 PASSAGGi B EL LFNETOONT STESSODTLnE L~ECALLIATIEEiLCHIEPROPRIE

DEL LApOTES recA.Aaial pId IllcM ,impoole.airrpiica., as deolasanalau d oisI.IcoiaIIIo.te limisia Ic cessoo .J.1 1A

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p pee. qacto I dc1.1IesaIencsL IAl ~lolnsidacpooriaeIeia ten 010 nhiteInaI Indict II,piant di-1 rlS I- didoaIse pAnfzolo.asil bas nIramics soIllsI,1 dorsetc 1 iLapp di comrton prainsid onco icaita nI.oa doorabbera icirac so oilzon e roai Osan- L01:.nLnt

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ipiano Prneoai,nooa e neeionap Is. .Laglia Ilrcaain- II.ddiineeeoill p com

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pr ras 11I Ie inenr. t Pall er oAIt ,,dirbte Ilor a Ija IsOragratdbrcanilraiototaI dk tai ere nurr en rresgseoatrjrp soInIa ati betsl 0 sirorr P00,deluI kr -rr keetsrO jI-ikafaeI aso,, I 1,U M IJIeeIIo~Eer .

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KIRLIRCE Oba DISKUTERAALLA PATIENTPEECIPIKAFYPISKA CON MENTALAOOGRASNINdGAR00H ALLA ASPEKTOR AOPPATioENE 0004 DONNA EOaaTFP MOD EATIENTENFORE PERATIONEN.D~iskLSolare Lop IIoader botrrsir- r m1 IIa

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lan "Ibmoan siDsoaed Delta tO,a. llmolga rtoaaporlior. v.l no passandosloobIofn

or syolAIS, Oardpotohlto..- osoI . llaloa I.,dietIoSppEd llt la-tIarknIsk temarnkikola I.. I 00 aa pafomorolakatol tarkotobr bios.Ielis"I - pdr Abanmta oroa kImrnison Oisa.p.Rkiola Fodemade katonddos ITnobd .sra pdlomroTietEo Rllrhrd

re-i-eskioo ratnoseaor napR6edesltvil alt. IbrNAspoReboa sap ipolotor doetalead poalete noblagosatuisodIt. IoaIllsreombro Ensralrfiodra ltro I.IrnlsltR.1Ik- o I..apdo iler paaorrn as imtIrInlet OaSI, lii p00m pal-.as trarelo, WTrosiirgpn impinetatt prO as edrdlnod assosar rodoeIep, as doss lolooIta.S risNbga. No..r asi .C tepaatsNk1 soI pInor v.,,.o bllor pdfrostinpnTn,dbd dot Lbirni mod.IalaloorISnrpotdoI oilkot Oar1Ida llt ioseis saTimpRT, tl r ~re eaiorirsns

ipsatbilloNp00 Oepkiasob olId be hoatrds.b

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Roe1brreaatrbso okmmoeos lasnadn r ond.soretlmo-asope n ailorteoteramdotlatisel atipintto

trdIsgr ptno.k. sasom,spk.,mt no bdi traIPrspbft rogioror koorosoptia o1ilerOsiis asipirnll atita ear dooso tkrodiearosmaospogonrlParo~milptasaraar s lois ppprsss il ~bhobaNbfsP aab ole nlr.Dela- pariceton ks

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POR6iTIoHOTEAT.ARDER.

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DEn' AUIOOSNTMNTS I ER0T.*ig EARIA,."OOR DE C....A LoPedlnj do Cadoro Auootat 5 los Edlel do Code's 5555-1so desrco-fos enssrossi d ird pIdoja en ls fle hay

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do aray Iossos nesia usa aja " -55As-a sesse in-ern dies aladoya .mlsod ar.las S rpsse0 oa 5. LasCar es0.000

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CO.N.TRAINICACtONES

as-- .- I. via Iai fIascidesadI..aso ssadaosdadI 'Isotraal ec 5010d paso aopasnasIeljmatcose dI.1

4. Eslarmdad as Chrcsae Paato

aps1Aprdarlsal Ips.d,e s d dd l

aI osoza seediod sas oos11idoaaoyad 1, ss a-s IaaadAL I Sar ceatal asodot LHMPO ado cold UH.W." 0CC. sspadadoI,01-1

AISERTENCIAS V O5RECAUCIONES CUIOAODl

pooobanmnodn~ieas..do.ona qu, on of.as ..n oAtlio ocotbofaro UHM0OE.,I.. ebo.os doZirooniaostnbtll.a.danconit. producen una EaDa rndad an paouts to.nidad total do par a..6,t nos ha. dotooninodo Dobids a to Iimitado

inspTlsnaido. E.ototsd do codor .no rg htmlon par..n

dosarrottad imprfoidsod... oooodia pAdefarormisorpa tatar.Eda. otia Ind-yo -ea niomp. pro.tosi.t do enap.Ls osaps d.la, retiaro otropsnott dootnodasa.usa

*Lo o prtests If0 nana. ol..... Au.nq.ann.o stases tado hobo,

*Unnaote dd doIn-an a ol daito .. do to At i, Amooeoido Osaoneiic Ojacid peuinnatdoootgtosoa. Cosoidotor

M~OD..t Lao cordicooses~niAlentesad IadIAeast . o- e ojaa eeo a panne, ass- gras sco, 5D01 mienbra afotade ta fle sore I

4.Alto-ivldo ac~isidadddlpcne IP.,onbi land. ocids. 0. Aicod al alcohol a o ag I.1Otrnirccpai dadno,,sorasso.d

CUIND0D: Las cardici-r aIparirtI Aiedrase- dsnro-nnr lIcdsI doleonrplatens IsfD

Paso el "itlt Ihi. ieosnmoies. d II.espiso do sooosoai.o isrropooos002.Hittado ilEcIares -geeneelos d.Deooo .. daso tilac a aen paicd. ....rs.eso aIdno as 1jdC011D seoa

8nE.. -1oion I..do es 1,010-1 -I dd.l~. i .A11l 9. esaucdae do stlso nti-o-lsies leodocir ro. ,1dillsySails.d

LOA... OL CIPUJANO OErSMNNADUELI PIOTESIS CECADERAES IA MEJOROSION OdODCAIISFCdIBLE I .D.CD USAtf CEcAEROTESE ONUN'ALIENTE DUEPA.AEI LUALDUIES DOLAODOLEPSCASAPIThlCtAAo0 ONUN PACIENTE DUE SIMPLEMOENTESEAJOVOND AL PACIENTE LOS LIMITECCE RESISTENCI DOLE MATORIALESUSADDI EN OL I ACTIVO.ES MPI~dATISODUESE CXPLIOLtE DISDOSITIV I SARA LA IJACION ADl COWe LA NECESIDAI2CCNlSIGUIENTEDE REDULI 0 ELIMINARSUSTANCIALME5OTE CUAELDUIGRAEOLAS CONDICIONEI ANTE.ICHAS. 0I tratarenleor a1irdeic I ooasspneaniao -ucote co1nto -rIddooidsI . .Ins aan II 000snlcan 1 doida tIe coe.dicisesoiso. o actitadno . d-bodedereddnounl- asinpid III pacloet ocula too ioSracc.,Isr delIciraiss paedo aanarI rooopnrooidepetportisy/oamatrorioo do.eble adnonas Ideofoso Iaol doIs pedlsis a do InfiidoId Aito ort.1

or canls do peri~ds, fenders000d Igsedo ,nel-el. aIllnprd do .Aspedttis do ondoraso .sttoo La 0I an otaemeor olsatoidaanno-eel. So dote Isf-ser al pocort floeII facrar tabs costa~~idia Eson.s groa post WTtnctsrednngospes 5 clodod paden INFORMACIONDE WEPL..

ANTESDO LA CIRUGIA, EL CIRIJIAND EDEEDISCUTIR TUCAS LAS IMAITAOIONE.FI SCAS Y MONIALESPIARTCIRUAS DEL PACIONTO All LOUD TIDOS LOS ASPECTOS DOLI CIRUGIA P DE ESTA PROJESs GAe ars discas in ondobeeIIIerLas-e liscoe yusI posible

as-del roo las do 1IneTiccI-6do.p Iaencodidd IdosogaiIao IDoto loam psoreperoTio -e cola. -soiolsolt rospoI a Is uctirdad I. .aIpsdol pacienlo L. pluelfiodo EropraiaI Is thoroicssailrriscorIs.1 inplsesoid Idoestn pedleis do auddor ha -slaienade do 0opdniqoiiedraiIadseie ids asecero o d-sas- . do machas padrois dosoddorsIl cirajere to Idboe Onp-ca I asscliroc do eta pad...Idnois sores dohbos famLiuipadodc-rpor mrle toe Ia DIt.ir do -Impllai6as apca.Ciores medespodo cambiss~A1 arI d,. t.Iompa

IIIalaridad a a fle nI. acortoejad 001551peIdinrtoTmb.~iesha fal y. oid-o sebrotr-iooica sareLIoNTopan poodonolleroa do

Co. -,ay. - ,i iI .d'l, d I --- DIi-I..11~d .totIn....otion ,,I -d diI d ,i_.d So oncamlodib leoeraonroeo.dantoI Ti.gi. odood doescmposo do, la .taIe esobecdo pars pArIs.ied-teoio,dcopolrte

Ia ertsanamco00laAis m-d.Pas aamdooos S Itjsu pstetoa, flee ascanonoto 11550pr ite-oto ion. N, iasar coadmeora o ponstnshaste.... es v.., cabozu fmcle Ic

do paoisAsse oaaI noor limpftols rost -Is do-lesluls as codec o-piga esashocdsiatdol. IIIag femr. 00

rooideso n co 1d 1ILao.ms-rsnA Obo pII ictofori In fioIdn do ebsn Is aslcir oslosocido1s posters. -iiircseo atdl L,.1i.I rem

110Smrstu~.1.1IldIs oa .eesd stesgatn Aidstcltazd 6,leoosssaonot.Tara pidelcrzAfemoat -Di - saodocnesnr.ddespeee,dim iastd,-pol

comeoreleddocoeblad tIs55 Idi-poscd Onprledo~.I c-doe S.totalpeeo ict 1 retcitid pds

dioloods doIs orricaladide.di I . ddcId.idi.-Il61ldi- ,d.d ddOdes,001iore do.Ia ",ift.id airdsoic so.- ded iea o ootle sassds osmns00 s o06,Scsolpses

PnprAtle, 1dc I- .3 Ld .It-Eds .Idosanoitsspbeor,-oacia Daopeie00,nstaomoesndeteosesrcioe dollea-c. DareI~0,ntoelpelededoaddudpsss..e.u-iaa dei~deosgis boos,.1.d.Insaersolaloeto. AIb. . 1. 1I i~.I ~ ,.. .. 1A .Aa I oddriaoaccono ydaordsoiaoas ,.d v. nrapid caoeeiorlmrtAc.cndooecaosatodnatoucusdo plosIrellrntnseiesors1 I o

Iras coeun oeo parsd-d acatos so pose asandodonbmolotnoa pdnipiILIdde -d,~r . I . srorierrrroeooosnmaliOrssot

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na.. k.~~na~~~~~rn w. mands ~~~~~.,L,- If..m sA.A-ada aa~~~~ a . y . .

taclore dtlindos en AOVEPTENCIASY* 000 100, did do los c-opones do Ia prtei- amolodo d -nairdl o

RRECLICION0ES.-d.W

IANVtERTENIOASRRECALOCINES-o AoioaaloasoroldotlladsO or, AOYERTENCIAO Y RRECAUCICNES.iAI-lro3. ......Tutdo aiadlssoofrsa.

4. Idqat coprrl olcotd rcelrot o desalados 0,1 AOVERTENCIASo (sotur del oploioo Los tactor

PROI;AUG010004 i.I1-tec.duteI.tttrsno olrda

fiorlac"Id do rosido-a causado P.t 0 desqool . pASllolo do -e-tI.l doproodidNa.

1.P.rsAcdoeabl.

.1BoooosasssroiOo~oi, rtni fretlI.obs-dri'lisl..''. . i olamne o tosolo. odolroo, odslAra 0.porososoisladot. o, . . P~lA,5.II tmoa

0.S~idIoos.6 . dAs ocood do In arisulac idt ocdr obd l oeciod uos10ooloain dot rdni.In tfsslo do osmprores oy I Ilojoldad.lr~d aolr5tbos

d.ou-dALAides dislocacid PosL-praio Sadi I.Assdessaldiocusd o ocss tri-muclr opl6opeo oil1cd orloI sonitocdsaldltocro

op ls blo -Ia In do lais1 dorm do io 2A.AotauaiorT ddo po oea iIriando oi .10 a or d d s .poaoanso lrsarran aI

Adis.eocodo Lrila olrd l'As irom dainitttoa / oiioisaclo

d.,mioetbro durotrnlnnltsgla4Ii.A-mdrrornOcadlsts,,dillaipsblnIoAsl.assa dO~o-lNpdara I

.SouaSids0didseolds. 'A.IdP.-dIi--~.

6Ld itui dilicalodn , quo otI Lossprstoe orioesld. toodprborE ~m-ros es dslosproo ,miotsorcsd puedr od o Ia obenis do

Apicoirtd irisdAr, doP'-onIort dOconoiur A 10loodo do smsolteo1-1- Esil m-isaid aossspc po"ar

MOD O DEISTRIBUCIN ersr d, .il. IpaoadprialPscslnl sossisistrap eotAquesdosLo Odtaostpoeo- d ossrlooOna . aslbulr.1 Cadets

itiodiua~-Losst I EOTERIE .Tdslsotpoolsloais 0srmcss sniia 0 ~sisdr --.o opeooA1do UHMWREs

-AdADOLLIMPIEZA

tria1s.l .,ooo dot.ismdint n IpredacloII. .lnocisrodproductsP -505dosoosotliood.111-. S . i .d

ESTERILIZACIOOIlopnrtromtluoe.mno

.setLidod (SALl do r Meteor Cas~~~oTomporo...r. Eopcinido

rodttpps S no apl~icablo,dseuiIn pOilcasoifns`osilic del osDblisir.

CUIDAD.: NO SE PUEDN o..l...lloor lo. caboose ton-rol do notria, p-tst net r-ooirnoltoco- mlc 0coieoob

-.nlAc~ndoed. do II.n rnnbeooooUHMWPE.No.. arrotor. no el 1 ocpqn~o.aneo aro colo dA.od.

INSTRUQOES DEUTILIZAQ;AO

CDIJIADO:A Lci Fodoro (E.U.A.)Hiilaaeot.do doIN lpreitin A Itt di.. on pEr ordo do at, medic

OESCRI9AO DO DISPOSITIVO PR6YESE TOTALDA ANCA

UrnIloree Totaldn Asco compostapol temoro~S do pol oub,. tooraL.a dala00Lr a ocrls ooCsd da-arc Po.ol

JIHMWR rotorldas cor LtIM, sod- lacdridioodos lodisdool-Ist. ,0dosl so-s 0..sobliait ssopntisi ar.ticola~-aurl. doorticalapf do~

PR6TESE DA MICA SELF-CENT'tINGrO

1 oc do .otos .. 11. d O f11

.slor- do i.sort do P ftolot.odo arco Sell-Conoitqotitr1 doJAobsslILoIronoq olurn sr , do teoeoc- doplastics ara son usIizds c,,rn IAat lloetNIhaoot didror corosodotlo so dinmelr1 loot.oti so sobseilais200ao- dofirc. A Prdlns da AtopS.poll-Ceteir tocbpnaild con polo do ul1ra Pdto Total do ,c

daudNa- do1moa dood. irsoro do UHMWPLl . -15csid corn urno oroa Idocosa desiaroa Acnood urns lot a -P1,d0 co

I~ a nlool d. .ecd. Nosro leop00 or o.cl ooos do cabi.11Oplertoornl dun o. -dloordspad-s so elr A .odalar 11fdopsIs

PR6TESE PARCIALDAANCA

UTILIZACAOA DUE SEDESTINAOINOICAQO.. PR6TESETOTAL DA ANCA

A 1d,1N0101. s itdtnd.oS do ars- par. proporSi -non urna rIst Onblidode so dsontoeedsOIt dor, sosiWalodIdtroa otliculo do

opts idicads too seoito cod-o IU-n arscoa- s rootornsr ddlrAn- 0/oi-opntd r r. ddosrl toudica a-tito r.Ornldido so dooesuLbt do ori

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Draft labels

53;3~ 41

(b) (4)

(b) (4)

APPENDIX C

*DI' lI I ..ABr .P U I(,AI I( )\

LABEL - MAIN PRODUCT

REF 9998-03-944 T i 123456789 ~, 2003-10 STERILE-R

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,Uaat 44 ESTANDAR DUOFIX

Protesi acetabolar* ttlaiM:sura 44 STANDARD DIJOFtX

Impanle accetaular totaI

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44 DUOFtX

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LABEL - TRANSIT

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AUTHORISED: f, SOP No. 8-06 Issue 3

42

(b) (4)

(b) (4)

(b) (4)

APPENDIX C

~ ~ ~ Al..Bkl. SI'I;CI[:IC:\lION

LABEL- INNER

REF 9998-03-944 C[' 123456789 2003-10 STERIL'E-

DePuy ASR'"'

TO TAL ACETABJLAR IMPLANT

S:Ze44 STANDARD DUO tIX

i 5 tt._SS Dp2,E: CP DAGA!l

,mpla,,t cotyIlodiefl toatlTaill a STANDARD DUOFIXSTERILE SAUF SI OUVERT 0U ENDOMMAGETolI-Atze wbtu I ui,- Im pianltA

Gr,0l 44 STANOAMD DuOFiX

NUR STERIL WENN NICHT GEOEFFNET ODER BESCHAEDIGTTotaal J abeumimplantaalMat A4 ESTANDAR OUOFIXSTERIEL TENZIJ GEOPEND OF BEFCHADIOD

Pr ote.~l acetabolare oloaleMFsura 4 STANDARD OUOFIx

STERILE SE NON APERTO 0 DANNEGGIATOImplsnte acetabulat totatTamio44 DUOFIXESTERIL SALVO ABNE Rty 6 DANADO,mplants total para acetabulo

'am,anho 4 STANDARD DUOFIX

ESISRIL A NAO SER DUE ABERT7 OU DANIFICADC

,; 44 DUOFIX

* D~epuy n.., $t,? SI C,Ž Ltd St

LABEL - DISTRIBUTION & PATIENT

.EF 9998-03-944 .L-OT- 123458789 2 2003-10

DePuy ASRTM SiZE 44

TOTAL ACETABULAR IMPLANT STANDARD

!, -. fljj:!J j! IItl

SOP No. 8-06 Issue 3AUTHORISED: ~

3 3143

(b) (4)

(b) (4)

(b) (4)

; De~iv LABEL SPECIFICATION · ______ LABEL SPECIFICATION

LABEL - MAIN PRODUCTREF *998-00-141 L~OT~7] 123458789 2003 E

9908-00-141 FLET200307 ::6. L

DePuy ASR"TUnipolar Head

rMAT7L C 0085

Tite umrpoaireTfdlIe 41

Gidit 4'

Unlpolacre kopMaat 41

Testa Urlpoh1feMsijsra 41

CabeZa u4.polar1amab* 41

Cabeca un~polaITananho 41

( f 41

ODOPUy:LESS'g-Er nrI

UK

AUJ'tHORISFD: - SOP No. 8-06 Isue 3

44

(b) (4)

(b) (4)

(b) (4)

O[~OU~ ~~~ ~~~~REVISION:l_____y LABEL SPECIFICATION

LABEL-INNER

RE5 9998-00-141 r¥§n 123456789 . 2003-07 sEs R

DePuy ASRT M

Unipolar Head

Size41

E*R LE I NLSS OPE'..E OR1 DAVAGE-

Tet. wnipo2aireTadle 41STERILE SAUP II OUVERT au ENDOMMAGEUnipolarer KopfGrole 41NUR STERIL WENN NiGCHT GEOEFFNET OOER RESCHAEDIGTUnpolare kopMaat 41STERIEL TENZIJ GEOPEND OF BESCHADIGO

tJ~l. u,"pla,'eM!muOa 41

STERILE SE NON APERTO 0 DANNEGGIATOCabxnza ,nlpolaTamSa 41 &ESTERIL SALVO ASIERTO 0 OAIASADOCabt;a unipotlaTanmantho 41

ESTtRIL A NAO SER QUE ASERTO OU DANIFICADO

FMAWT C FRxiyX I C CEc08e -

* DePuy, _ernlT E¢aI

LABEL - DISTRIBUTION & PATIENT

REF 9998-00-141 LO-T 123456789 2 2003-07

DePuy ASR T M SIZE 41nimolar Head

* DePuy.

AUTIIORISED: t SOP No. 8-06 Is,,e 3

45

(b) (4)

(b) (4)

(b) (4)

APPENDIX C

De~~~~~~~~~~~~~~~~~~v~~~~~ \(ABi SI()I 1 10

LABEL - MAIN PRODUCT

RE; 9998-00-102 LOT 123456789 : 2003-09 -EtLE'R

DePuy ASR TM

TAPER SLEEVE ADAPTOR

12/14TA.ER +2 C.

MATL[ C C386

RACCORD MANCHON CONOQUE12.14 CONE +2

KON'SCIhER HULLENADAPTER1214 KONUS '2

TAPSE MANCHETADAPTER1214 CONISCH +2

ADATTATORE RASTREMATO DEL COLLO

1214 CONO +2

ADAPTADOR DE VAINA CON CA12f14 CONO '2

ADAPTADOR DE MANGA CONICO1214 CONE *2

MAENUK

~Z'14___ __ - .L-

AUTHORISED: SOP No. 8-06 Issue 3

46

(b) (4)

(b) (4)

(b) (4)

APPENDIX C

* Dea y ____

i.\13'l1. S;i'ECIFICA1I O >

LABEL- INNER

qEF9998-00-102 jL,1J123456789 .2003-09 s'TERI-"-

DePuy ASRTM


12)14~~~~1 7TAPER +2

RACCORD MANC44ON COMOQUE

12j14 CONE .2

STERILE SAUF SI OUVERT OU ENDOMMAGEKONISCHER HULLEN.ADAPTER12114 KONUS "2

NUR STERIL WENN NiCIT GEOEr;NET ODER SESCHAEDIrT

TAPSE MANCHETADAPTER12¢14 CONISCH +2

STERIEL TENZIJ GEOPEND OF SESCHADIOD

AQTTATORE RASTREMATO DEL COLLO

12,14 CONO +2

STERILE SE NON APERTO 0 DANNEGGIATOADAPTADOR DE VAINA CCNICA12114 CONOI2

ESTERIL SALVO ASIERTO 0 OAfJADO

AO APTADOR DE MANGA t&NICO

12114 CONE .2

ESTERIL A NAD SER QUE ABERTO OU DANIFICADO

12;14

0C136-De~~uy ~;;:'1;T;;-V LIZ St Ar.Id'VISR

0~~~~~~c~ NPll 30T Endar ld

LABEL - OISTRIBUTION & PATIENT

REF 9998-00-102 FL.o"T" 123458789 , 2003-09

DePuy ASRTM 7..14,TAPER


I 11,1ttlit 11111111111It

410~ ~ ~ ~ ~ ~~~~~~~4

AUTHORISED: SOP No. 8-06 IssueS3

47

(b) (4)

Previously Cleared Ultima Unipolar Labels

1A+H441852623

*+$AAAAAAO@OGJf

l1!!L¢C Il 2004-,3

ULTIMA*12MM EXT UNIPOL AOAP SL 1AAAAAAOOOKM85-2623

MFG: DEPUY ORTHOPAEOICS INC

. EU EAaTI4- LI'EpUy ORTHOPAEDICS ST RHIHOH¥VS ~004

tAQSA4.IN46581p.O. BOX 906

LEEDSLSI1 DOTEHGLAND

U 800 3a6-643) +44(1131270 0461

1-0I+H441852623

IIDIIIIIU111II111tllVIllhllIIHIhII0IIh~lIIlID IlhhlIl 8IIIlll 0+$AAAAAeOe@J0

MinLI CI 2004-03

ULTIMA*12MM EXT.UNIPOL ADAP EL IKM85-2623 Io AAAAAAOOO

MFOz DEPUY ORTHOPAEDICS. INC

DEPU¥ ]HTERHA4TTOHALLIDDEPU¥H CRTHOPAEOICS-[HC-51 AHTHOI¥'S ROAD

LEEDSLI] BIT ENGLAID P.O. BOX 888

.ARSA. IN 46561 U1BOE 36G-0143 ) 444(1I3)270461

MMSTyE0 DeR~

1 -2623 [ fljAAAAAAOee

ULTIMA® ADAPTER SLEEUE

-[111013 + m12

48

Previously Cleared U Labels+H4485262CEz

0086

M AITL IC

ULTIMA GRAMEXTAJNIPOL ADAP DL rIA Ca - [M I 00 2622 AAAAAAOOO

MFG: DEPUY ORTHOPAEDI CS, INC. ____

DEPUM ORtHOPAEDTCS. INC, DEPUY INTERNA11TIONALLTDT P.A HO O ST AN HNY'S OAD 4ARS'A'i LEEDS: SIt SODT ENGLAND 'IN 49581 1 0 3SG-8143) '44(I 3)270 04 1

ULTIMAG'MM FIETUNIPOL ADAP 81 200f0

605-2622 K AAAAAAOOO 2eI 0

MFG: DEPUY ORTHOPAEDICS. INC

DEPUY ORTHOPAEDICS. INC. DEU INTEQNATOL LID P.O.5255S AINHOYSOA

WARSAW INM41501 LEEDS LSLI O DTt ENGLAD 0 1-13B 4 4) ll31270 8491

0 De~jy,, O-TRL

ULTIMA®R AAAAAA0___

ADAPTER SLEEUE

11113~~N

49

Previously Cleared Ultima Unipolar Labels

lY,,+H441852621

.+$AAAA000BH. I"~tL IC j

2e64-e3ULTIMA*OMM EXT. UNIPOL ADAP SL

1 go AAAAAAOO08 - 2 6 2 I I IS 5

MFG: DEPUY ORTHOPAEDICS. INC. AL LTD.] IC. O(PU¥]H4TEDNATIOEpu¥ OQTHOPAED]CS

SI RNTHOH¥'S ROADp.o. IoxC gee ODIENGLANDU*RRSPA, 645G'44(IN 4G581 LEEDSLSII D13)2?0C1 890 366-0143)

IYCo+H441852621

1I11111111I008t~ll1111111JIJI1111311ll1111111111IIllII1111111111B .+$RARRAARO06H'

204- 63EXT UNIPOL ADAP 8LULTIMA*OMM

85 -2621 Io AAAAAAOOO MFO: DEPIJY ORTHOPAEDICS. INC.I

DEpUY INT[I0HAT[OI~L LTID DEPU¥ ORTXOPlAEDICS INC. p.O, sOygee ST RNNTONY'SQIND~[

LSXG eDT ENGLANDLEEDS

(1 Bee 35G 143) ,411?e7 *4E1 U*OISAU, IN

- 8 45501

_ULTIMA", RAF-PTER SLEEVE

35 50

EXHIBIT 4

Test Reports

51

(b) (4)

Index of Test Reports

1. 151/03 2. 045/03 3. 143/02 4. 283/02 5. 284/02 6. 043/03 7. 128/03 8. 032/03 9. 044/03 10. 307/02 11. 006/03 12. 299/02 13. 037/03 14. 145/03 15. 141/03 16. 082/03 17. 065/03

52

RESEARCH DEPARTMENTI REPORT

4b: Test report

4b: Test report

(b) (4)

4b: Test report

4b: Test report

9

4b: Test report

4b: Test report

RESEARCH DEPARTMENTI REPORT

4b: Test report

4b: Test report

~

4b: Test report

.5

~~~~~~~~~~~~~~~~~~~n._

s

4b: Test report

=-

4b: Test report

4b: Test report

~~~~73

4b: Test report

4b: Test report

~~~~~~~St

4b: Test report

4b: Test report

206

4b: Test report

4b: Test report

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~I

4b: Test report

4b: Test report

~~~~~~~~~~~~~123

4b: Test report

4b: Test report

~~~~~~~~~~~---*--52

4b: Test report

4b: Test report

134

4b: Test report

4b: Test report

26.

~~~~~

4b: Test report

4b: Test report

4b: Test report

4b: Test report

~~~~

~~~~~~~~~~~~~~~t~~~~~~~~~~~~~~~~~~

4b: Test report

4b: Test report

~~~~~~~~~~~~~

4b: Test report

4b: Test report

~~~~~~

4b: Test report

4b: Test report

~~~~~~~~~~~~~~~~~~7

4b: Test report

4b: Test report

~~~~~~~~~~~~~~177

4b: Test report

4b: Test report

184

4b: Test report

4b: Test report

~~~inear ar

4b: Test report

4b: Test report

EXHIBIT 5

HA Coating/substrate Manufacturing Information

194

(b) (4)

(b) (4)

Office of Device Evaluation Document Mail Center HFZ-401Center for Devices and Radiological Health Food and Drug Administration9200 Corporate BoulevardRockville, Maryland 20850U.S.A.

our reference your reference24 February, 2004

subjectLetter of Authorization for Access to MAF

Dear Sirs,

We would like to herein request that you grant access by reference to the above mentionedMaster File to DePuy Orthopaedics, Inc., located at 700 Orthopaedic Drive, Warsaw, Indiana46581-0988. DePuy Orthopaedics, Inc. will be using the Master File in support of theirsubmissions to the Agency related to our hydroxy

We thank you in advance for your cooperation.

Best regards,

Managing Director

195

(b) (4)

(b) (4)

(b) (4)RAW MATERIAL SPECIFICATIONS

'*i~i~'"&'? ~"~ "" " ~"

196l196

(b) (4)

RAW MATERIAL SPECIFICATION

197

(b) (4)


(b) (4)


199

(b) (4)

EXHIBIT 6

Predicate Device

510(k) Clearance Letters

200

OCT 1 320 Koozggs

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM: DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, IN 46581-0988

510(k) CONTACT: Cheryl Hastings Director, Regulatory Affairs

TRADE NAME: DePuy Pinnacle Metal-On-Metal Acetabular Cup Liners

COMMON NAME: Acetabular Cup Prosthesis

CLASSIFICATION: 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis

DEVICE PRODUCT CODE: 87 JDM

SUBSTANTIALLY EQUIVALENT DEVICES: DePuy Ultima Metal-On-Metal Acetabular Cup

DEVICE DESCRIPTION AND INTENDED USE: The Pinnacle Metal-On-Metal (MOM) Acetabular Cup Liner is metal liner that isa intended for use with the Pinnacle Acetabular Shells that have been cleared previously.The liner has a 28mm inner diameter and is offered in a neutral style only. The Pinnacle MOM liner is mechanically locked with the shell via a taper junction, and articulates with commercially available prosthetic femoral heads.

It is indicated for use as the acetabular component in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, ostecoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protnssio acetabuli, slipped capital femoral epiphysisand disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

The Pinnacle Metal-On-Metal Acetabular Cup Liners are intended for use with DePu,Pinnacle Acetabular Shells and 28mm diameter Co-Cr-Mo femoral heads only.

BASIS OF SUBSTANTIAL EQUIVALENCE: The Pinnacle Metal-On-Metal Acetabular Cup Liners are nearly identical to the Ultima Metal-On-Metal Acetabular Cup Liners that were cleared previously. The intended use,articular surface, material and locking mechanism with the outer shell are the same. The only changes are minor design changes that allow the liners to be used with the Pinnacle Acetabular Shells that have been cleared previously.

0000004

201

DEPART7MENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug AdministrationOCT i 3 2f 9200 Corporate Boulevard

Rockville MD 20860

Ms. Cheryl K. Hastings Director, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K002883 Trade Name: Pinnacle Metal-On-Metal Acetabular Cup Liners Regulatory Class: III Product Codes: JDM and KWA Dated: September 13, 2000 Received: September 15, 2000

Dear Ms. Hastings:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for theindicationswfor me stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have-beenqeoomesifedin accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control provisions of the-Act.4:honea control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandingand adulterationt

If your device is classified (see above) into either class II (Special Controls) or classJLl (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Partis404teo95. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS)for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

202

Ms. Cheryl K. Hastings

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note thenegulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fdagov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices

Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

203

510(k) Number (ifknown) KI_6 __

Device Name DePuy Pinnacle Metal-On-Metal Acetabular Cup Liners

Indications for Use: The Pinnacle Metal-On-Metal Acetabular Cup Liners are indicated for use as the acetabular

component in total hip replacement procedures for patients suffering severe pain and disability due to st-uctural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic artifis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusioacetabuli, slipped capital femoral epiphysis and disability due to previouwslion, where bone stock is inadequate for other reconstruction techniques.

The Pinnacle Metal-On-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and 28mm diameter Co-Cr-Mo femoral heads only.

(Division Sign-Off) Division of General Restorative Devices 510(k) Number 4 0-zW~

Concurrence of CDRH, Office of Device Evaluation

Prescription Use V OR Over-The Counter Use (Per 21 CFR 801.109)

0000005

204

Pubhc Healtr ServiceI)EPAHTMI.ENT Of HEALTH & HUMAN SERVICES


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4.c KlUIJ5 2 l ]l'idc ,.zt:c !Hi~tnaic

3 (!,:Hii NIclIkI;¥./-\ x'kf' '.\CCi~.l. I['8lI.':

I4C,!LktLotr (. I:Is< I

[rt'R,GKIC (odd' K[...\.\

12.t1l' Lw' k\\jiltkc:':

\\'x' iaxc ,:CC ICxxc \mir SeeCion~ §5I1it!(ki ix ,:.cLki,'!I c tw tII'kv.' tIhitI' Cv', k:e .cet

innICd ht1device is S, ,quiv'lent1Icr hi¢I:n\I hldiLttiplt tin' tqC,iN!',,' ;t v.,', haeC djtcr

,.taled in ihe c-nclu>Liv to devices m:, 'l,,.",.:O i! ink'rsui tc e(IilnhI ree Flk'F L [j(rt\1, 1976, Tiie

reeI::)si lI, illcn3;:l'.cr:'CiLdale : :..m NIL'JiicnI I )c\ic .\'orhttis, c1FIi devic:s th:,!lt jie een

Youfi ll.iv,;,,iJdtC I:I ,,ie prulxtsI\iuns d1'lhI I'cd,.'ral ioad. D)Iic~. a:nd (_oscotic A,\ct (\ct\I.

d.Lt zftT. iimrkei tie d,:vice. hi the £.CIILY. cLtll('iS J',.ibiNSi o@hck Act. Ike gc1c:ral-;ubihci

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I HIi 01 1 l -I: .tl! LI\ I> vUHS21C1I (se tti'O I [ILO vtfIv'C CLLS I, 'C i1, 1dv

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A\sisi~tal C(IUlI\ alvIlt &cr:vi1iHI>Ll1011 ;stmSdIii IIjII ,L~ \\ i'P 01' iP ILTI (u' 2 it;tice ~ tl?,llt. (.'otI c l' in ti QiliI' S\t'it-.lRccuiatUt0 ((SINlac~tiulet LI l'r Ec1 iv asi setC I r c 2 l;or

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,:tnipI', s,,ivhtl i.c(r\1 Iu ,,, JL',lu ni ti rcsil: ;It [egulator' .teliolnI[i Utut. l ma' publish

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IhC. '(12i ~LIti.~t~ 'cti~r(u IJWCIs ~I[L:rc~r filrlisUiv tic tlhli`,'111oliil it,!1A11 hip cJLC U : o~cL!1Imcs itr jm tit-stI Ltdisahil~x dueL7 slutii avaŽ iti hit 'trc'paIl air I

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0000004

207

JUL 1 2002

WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE ROAD ARLINGTON, TN 38002

901-867-9971

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the SafeMedical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as aSummary of Safety and Effectiveness for the use of the Metal TRANSCEND® Articulation System.

Submitted By: Wright Medical Technology, hic. Date: April 26, 2002

Contact Person: Ehab M. Esmail Manager Regulatory Affairs

Proprietary Name: Metal TRANSCEND®

Articulation System (LARGER SIZES) Common Name: TOTAL HIP SYSTEM

Classification Name and Reference: 21 CFR 888.3320 Hip joint metal/ metal semi-constrained, with a cemented acetabular component prosthesis - Class III 21 CFR 888.3330 Hip joint metal/ metal semi-constrained, with an uncemented acetabular component prosthesis - Class III

Device Product Code and Panel Code: Orthopedics/87/KWA

DEVICE INFORMATION

A. INTENDED USES/ INDICATIONS The Metal TRANSCEND® Articulation System is indicated for use in total hiparthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular

necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

510(K) SUMMARY WRIGHT

208

TRANSCENDTM Arniculaton System 510(K) SUMMARY Page 2 of4

3. correction of fimctional deformity; and, 4. revision procedures where other treatments or devices have failed

The Metal TRANSCEND® Articulation System components are for single use only. B. DEVICE DESCRIPTION

The previously submitted and cleared Metal TRANSCEND® Articulation System(Exhibit 1: 510(k) K004043) is composed of two pieces, a metal shell and a metalliner that mates to the shell by the use of a taper locking mechanism. This two piecedesign limits the size of the femoral heads. The use of a monoblock superfinishedshell allows larger head sizes to be used. The new Metal TRANSCEND® ArticulationSystem (larger sizes) should increase the range of motion and decrease the risk ofdislocation as compared to the current TRANSCEND ® (510(k) K004043) Metal on Metal bearing couple. The Metal TRANSCEND® Articulation System (larger sizes) consists of thefollowing components that are substantially equivalent to the previously clearedcomponents submitted under the Metal TRANSCEND® Articulation System (510(k):K.004043): metal monoblock acetabular shells, and metal femoral heads. Design features of the Metal TRANSCEND ® Articulation Monoblock Shell (largersizes) are summarized below: • Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM

F75 • Porous coated with CoCrMo (ASTM F75) Sintered beads* Available sizes: ranging from 46mm to 64mm (outer indiameter) 2ramincrements (The inner diameter of each shell is 10mm smaller than the outer

diameter)* The articulating surface of the implants will be superfinished (1 microinch Ramaximum) to insure form tolerance and a fine surface finish* A one-piece acetabular shell allows the surgeon to reconstruct the acetabulum

while removing very little bone to accommodate a larger Femoral Head. Design features of the Metal TRANSCEND® Femoral Head (larger sizes) are summarized below:

Manufactured from cast cobalt-chromium-molybdenum conforming to ASTM F75Available sizes: 38rmm, 40mm, 42mm, 44mm, 46mm, 48mm, 50mm, 52mm,54mm

* Available neck lengths: -3.5, 0, +3.5The articulating surface of the implants will be superf'mished (I microinch Ramaximum) to insure form tolerance and a fine surface finishThe taper connection for the Metal TRANSCEND® Femoral Heads (larger sizes)will be identical to the Metal TRANSCEND® Femoral Heads (510(k):K004043)and is intended to be used with our existing femoral stems manufactured with WMT12/14 taper.

5JO(K) SUML4RY WRIGHT

209

TRANSCENDTM Articulation System 510(K)SSUMMARY Page 3 of4

C. MATERIALS

The materials used for the Metal TRANSCEND® Articulation System (larger sizes)are substantially equivalent to competitive devices previously cleared for market. Monoblock Acetabular Shells · Cast Cobalt-Chromium-Molybdenum CoCrMo (ASTM F75) * Porous coated with CoCrMo (ASTM F75) Sintered beads

Femoral Head

* Cast Cobalt-Chromium-Molybdenum CoCrMo (ASTM F75)

D. CLINICAL DATA The intended use, material, design features, type of interface, and reported ware ratesof the Metal TRANSCEND® Articulation System (larger heads) are substantiallyequivalent to the previously submitted and cleared Metal TRANSCEND® Articulation System (510(k): K004043). Therefore, Clinical success similar to that of the previously cleared componentssubmitted under the Metal TRANSCEND® Articulation System (510(k) K004043) isexpected. The clinical data (TRANSCEND® Metal Articulation System Controlled Clinical Trial in support of 510(k) Statistical Analysis Report Version 8.0 December23, 2000- Volume 1 & 2) was previously submitted under the Metal TRANSCEND®Articulation System (510(k) K004043). The data was collected prospectively frommulti-sites. After excluding a single site with significantly poorer survival than allother sites that was identified as having problems with surgical technique, 2-yearcumulative survival was found to be clinically equivalent to (no worse than) theDobbs metal on metal cohort. Nearly 90% of procedures resulted in "at least goodresults" at 1 and 2 years as determined by the Harris Hip Score, results that comparedfavorably with literature-based cohorts of THR. There was more than a 50% increasein the SF-12 physical function component score. Complications and adverse events were rare. Radiolucencies >2amm were rare. There were no findings of subsidence of the stem or migration of the cup >2mim. In conclusion, this controlled clinical trial provides substantial evidence that theMetal TRANSCENDTm Articulation System (larger sizes) is as safe and effective asapproved predicate devices with clinically equivalent patient outcomes relative to such devices, thus supporting a 510(k) claim.

w SI0(K) SUMMARY WRIGHT

210

- -

I RANSCENDTM Articulation System 5 10(K) SUMMARY Page 4 of4

E. SUBSTANTIAL EQUIVALENCE INFORMATION The intended use, material, type of interface, and design features of the MetalTRANSCEND® Articulation System are substantially equivalent to the competitivedevices. The safety and effectiveness of the Metal TRANSCEND ® ArticulationSystem are adequately supported by the substantial equivalence information, materialsdata, testing results, and clinical data provided within this Premarket Notification.

w o0(K) SoIMAAY WRIGHT

211


'%%,,,4


JUL 1 2002 Mr. Ehab M. Esmail Mariager Regulatory Affairs Wright Medical Technology 5677 Airline Road Arlington, Tennessee 38002

Re: K021349 Trade Name: Metal TRANSCEND' Articular System (Larger Sizes)Regulation Number: 21 CRF 888.3320 and 888.3330Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular

component, prosthesis; andHip joint metal! metal semi-constrained, with an uncemented acetabular component, prosthesis

Regulatory Class: Class III Product Code: KWA Dated: April 26, 2002 Received: April 29, 2002

Dear Mr. Esmail:

We have reviewed your Section 510(k) premarket notification of intent to market the devicereferenced above and we have determined the device is substantially equivalent (for theindications for use stated in the enclosure) to devices marketed in interstate commerce prior toMay 28, 1976, the enactment date of the Medical Device Amendments, or to devices that havebeen reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act(Act) that do not require approval of a premarket approval application (PMA). You may,therefore, market the device, subject to the general controls provisions of the Act. The generalcontrols provisions of the Act include requirements for annual registration, listing of devices,good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), itmay be subject to such additional controls. Existing major regulations affecting your device canbe found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the FederalRegister.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

212

Mr. Ehab M. Esmail

This letter will allow you to begin marketing your device as described in your Section 510(k)premarket notification. The FDA finding of substantial equivalence of your device to a legallymarketed predicate device results in a claissification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 andadditionally 21 CFR Part 809.10 for invitro diagnostic devices), please contact the Office ofCompliance at (301) 594-4659. Additionally, for questions on the promotion and advertising ofyour device, please contact the Office of Compliance at (301) 594-4639. Also, please note theregulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97).Other general information on your responsibilities under the Act may be obtained from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 443-6597 or at its Internet address

Sincerely yours,

SCe a Witte, Ph.D MD. Director Division of General, Restorative and Neurological Devices

Office ofDevice Evaluation Center for Devices and Radiological Health

Enclosure

213

WRIGHT MEDICAL TECHNOLOGY, INC.

5677 ARLINGTON, 5 AIRLINE ROAD

TN 38002 901-867-9971

Metal TRANSCEND® Articulation System

INDICATIONS STATEMENT

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improvedhip function in skeletally mature patients with the following conditions:

1) non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis,ankylosis, protrusio acetabuli, and painful hip dysplasia;2) inflammatory degenerative joint disease such as rheumatoid arthritis;3) correction of functional deformity; and,4) revision procedures where other treatments or devices have failed.

(iiionSinOt Division of General, Restorative and Neurological Devices

510(k)Number KOZ t(Z'?

INDICATIONS STATEMENT 'WRIGHT

214

cuiflt ANDiouIfl~~rcasRA~~rnwtfltflwAYai~f

FDA Home Page I CDRH Home Page I Search ICDRH A-Z Index I Contact CDRH

5 I Registration I Listing I Adverse I PMA Classification I CLIA

Events CFR Title Advisory I Assembler I NIIRIC Guidance Standards 21 Committees

New Search Back To Search Results

510(k) Premarket Notification Database

Prosthesis, Hip, Hemi-,Device Classification Name Fmrl eaFemoral, Metal 510(K) Number K965156 Regulation Number 888.3360

Ultima*Unipolar Head And Adapter Sleeves Johnson & Johnson Professionals, Inc. 325 Paramount Dr. Raynham, MA 02767 0350

Contact Sally Maher Product Code KWL Date Received 12/23/1996 Decision Date 01/24/1997 Decision Substantially Equivalent (SE) Classification Advisory OrthopedicCommittee Review Advisory Committee Orthopedic Statement/Summary/Purged Summary OnlyStatus Summary Summary Type Traditional Reviewed By Third Party No Expedited Review No

Database Updated 2/06/2004

CDRH Home Page I CDRH A-Z Index I Contact CDRH IAccessibility I Disclaimer FDA Home Page I Search FDA Site I FDA A-Z Index IContact FDA I HHS Home Page sic

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pnm.cfm?ID=95094 2/24/2004

215

].

2.

3.

4.

5.

Summary of Safety & Effectiveness Data for the ULTIMA* Unipolar Head and Adapter Sleeves

Johnson & Johnson Professional, Inc. ' g.. .-:' 325 Paramount Drive

Raynham, Massachusetts 02767

Contact Person JAN 24 997

Johanna Newman, Assoc. Regulatory Affairs Specialist, (508) 828-3268.

Device Name

Proprietary Name: ULTIMA* Unipolar Head and Adapter Sleeves Common Name: Hip joint femoral (hemi-hip) metallic cemented or

uncemented prosthesis Clausifiatsn Name: Prosthesis, Hip Regulatory Clam: Class HIby 21 CFR § 888.3360 Product Code: 87 1DG Owner/ Operator N 9001269

Device Classification

Classification for ULTIMA* Unipolar Head and Adapter Sleeves has been placed in Class 11by 21 CFR § 8.3360

Statement of SubstantIal Equivalence

The safety and effhctivcness of the ULTIMA* Unipolar Head and Adapter Sleeves is substantially equivalent in tus of fiuncti to the Johnson & Johnson ULTIMA* Unipolsr Modular Head and the Hownmdica Uniurax Unipolar System. Furthermore, analysis reults demonstrate that the ULTJMA* Unipolar Head and Adapter Sleeves meets the set criteria for the establishment of "substantial equivalence".

Indications for Use

The ULTIMA* Unipoclar Had is indicated for use in conjunction with a modular femoral stem in partial hip replacement procedures for patients suffering severe pain and disability due to:

I. femoral neck fseture, 2. avascular necrosis of the femoral head, 3. - osteoarhritis, 4. abnormalities where:

* the major pathology affects the femoral head, * the acetabular cavity is normal and not deformed or weakened, * acetabular replacement is not required or desirable.

f2

216

6. Physical Description

The ULTIMA* Unipolar Head is provided in a size range of 38mm to 63mm (outer diameter), in Imm increments. Sizes from 44mm through 63mm are manufactured as a two-piece assembly. The two pieces are made of cast cobalt-chrornium-molybdenum alloy conforming to ASTM1:75. Both pieces are treated with hot isostatic pressing and solution annealing. The two cast pieces are machined and then joined permanently by electron beam welding to form a hollow unipolar head. Sizes from 38mm through 43mm are cast from cobalt-chromium-molybdenum alloy as a solid head, and are isostatic pressed and solution annealed before machining. Both ofthese size ranges are finish machined to the outer diameter size. The outer diameter is highly polished for articulation with the implant recipient's natural acetabulum.

The ULTIMA* Unipolar Head has a tapered bore which can receive a variety of Adapter Sleeves. The adapter sleeves can be tapered on the outside to the mate with the unipolur head, and tapered on the inside to mate with the appropriate femoral stem trunnion. The adapter sleeves are available in a 10/12 taper, in size increments for -3rmm, +0mm, +5Srm. and +10mm neck lengths; in a 11/13 taper, in size increments for +0mm, +6mm, and + 12mm neck lengths; and in a 12114 taper, in size increments for +0rnm, +3.5mm, and +7mm neck lengths. The adapter sleeves are machined from cobalt-chromium-molybdenum alloy in wrought bar form conforming ASTM F799.

Table 1. Similarities and Difference Matrix

ULTIMA* Ualpelar ULTIMA* Ualpelar Howmedlea Unfiax Head and Adapter Modular Head Unipolar System

DESIGN Range of sizes 3Imm-63ram 3Smm-6Smm 3Smm-6Smm

(tenmaemmeets) O(me increments) Adapter sleeve for Yes No Yesincreased neck kno Number neck length 1O/12 taper -3m. +0nmm +5ram -4mm, +Ommn,+5mm. sizes +4Ovm +Sram,+l0m +10mm

: I__________(1mm increments)

11/13 tape. +Omm, +6mm, +12mm 12/14 taper.+fmm +3.5mm, +7rmn

Morse-taper locking Yes Yes Yes mechanism to modular fermor stem

Pai hali ceilMet Yes Yes Yes

MATERIALS Manufactured from Co-Cr-Mo Ye Yes

12

217

Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration Memorandum

- x e -r wFrom: Reviewer(s) - Name(s) E2T h

Subject: 510(k) Number

It is my recommendation that the subject 510(k) Notification: The Record To:

B] Refused to accept.

B Requires additional information (other than refuse to accept).

12is substantially equivalent to marketed devices.

ONOT substantially equivalent to marketed devicdr.

B]Other (e.g., exempt by regulation, not a device, duplicate, etc.).

Nf NO Is this device subject to Section 522 Postmarket Surveillance? BYES

EBYES 1j~ NO Is this device subject to the Tracking Regulation?

BYES [ NO Was clinical data necessary to support the review of this 510(k)?

RIYES El NO Is this a prescription device?

BYES [ NO Was this 510(k) reviewed by a Third Party?

NOBYES Special 510(k)? U NOB-YESon H Drive 5lOk/boilersPlease fill out formAbbreviated 510(k)?

Truthful and Accurate Statement B Requestedtl Enclosed

B]A 510(k) statementS1A 510(k) summary OR

The required certification and summary for class III devices IS

]The indication for use form

Combination Product Category (Please see algorithm on H drive 51Ok/Boilers)

Bl YES B NOMaterial of Biological Origin

Animal Tissue Source [] YES 0] NO

The submitter requests under 21 CFR 807.95 (doesn't apply for SEs):

B] Continued Confidentiality exceeding 90 days Bl No Confidentiality B Confidentiality for 90 days

Additional Product Code(s) with panel (optional): Predicate Product Code with class:

Final Review: (DivisionDirector)

Revised:4/2/03

"SUBSTANTIAL EQUIVALENCE" (SE) DECISION MAKING DOCUMENTATION

K040627

Reviewer: Elizabeth L Frank

Division/Branch: D.GRND/OR.DB

Device Name: DePuv ASR m Modular Acetab~ular Cu Sy~stem

Product To Which Compared (510(K) NumberIf Known): K965156. K002883. K003523, K021349

YES NO

1. Is Product A Device -X ITfNO tp

2. Is Device Subject To 5 1 0(k)? X If NO = Stop

X If YES = Go To 53. Same Indication Statement?

If YES = Stop NE4. Do Differences Alter The Effect Or Raise New Issues of Safety Or Effectiveness?

5. Same Technological Characteristics? X If YES = Go To 7

6. Could The New Characteristics Affect Safety Or If YES = Go To S Effectiveness?

7. Descriptive Characteristics Precise Enough? X If NO = Go To 10 If YES = Stop SE

8. New Types Of Safety Or Effectiveness Questions? If YES = Stop NE

9. Accepted Scientific Methods Exist? If NO =Stop NE

10. Performance Data Available? X INO=Rquest Data

11. Data Demonstrate Equivalence? x Fia ecision: SE

Note: In addition to completing the form on the LAN, "yes" responses to questions 4, 6, 8, and I11, and every "no" response requires an explanation.

K040627/S2

(b) (4)(b) (4)

l. Intended Use:The DePuy ASRTM Modular Acetabular Cup System is indicated for use in total hip replacement procedures forpatients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis,osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures.Use of prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysis

and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

2. Device Description:The acetabular component is designed as a cast CoCrMo alloy (ASTM F-75) one-piece cup with Porocoat®

porous coating with the addition of a hydroxyapatite (HA) coating on the outer surface. The acetabular shellhas a highly polished, superfinished internal bearing surface, and is available with outer diameter sizes 44-70mm in 2mm increments with inner diameters ranging from 39-63mm. There is no separate liner component tothis system, as it is a one-piece acetabular shell used with a unipolar femoral head and a taper sleeve adapter.

The uni femoral head is manufactured from cast high carbon CoCrMo alloy (ASTM F-75) and is available in arange of diameters from 39-63mm in 2mm increments. All of the uni femoral heads have an internal taperwhich mates with a CoCrMo taper sleeve adapter specific to the 12/14 or 11/13 tapers corresponding to the

external tapers on DePuy femoral stems. The femoral heads have a highly polished, superfinished exteriorbearing surface, and articulate with corresponding one-piece metal acetabular cups. The sponsor states that thematerial, outer diameter, clearances and surface finishes of the

) are identical to the subject unipolar femoral head. The diametrical clearances for allfemoral implants (femoral heads to acetabular cups) range from 100-170 microns.

The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The modularity ofusing taper sleeve adapters in two taper options allows for a reduced number of femoral head components whileoffering various femoral head offsets and compatibility with multiple femoral stems. The ASR 12/14 tapersleeve adapters are manufactured from forged cobalt-chrome-molybdenum (CoCrMo) alloy. The 12/14 tapersleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters aremanufactured from wrought CoCrMo alloy and were previously cleared in the Ultima Unipolar Head andSleeve (K965156) and are offered in neck length options of +0, +6, and +12.

EXPLANATIONS TO "YES" AND "NO" ANSWERS TO QUESTIONS ON PAGE 1 AS NEEDED1. Explain why not a device:2. Explain why not subject to 510(k):3. How does the new indication differ from the predicate device's indication:4. Explain why there is or is not a new effect or safety or effectiveness issue:5. Describe the new technological characteristics:6. Explain how new characteristics could or could not affect safety or effectiveness:7. Explain how descriptive characteristics are not precise enough:

Descriptive characteristics are not precise enough because the sponsor must demonstrate that the newmaterial, larger diameters and larger diametrical clearances produce less wear than the predicate metal-on-metal systems.

8. Explain new types of safety or effectiveness questions raised or why the questions are not new:9. Explain why existing scientific methods can not be used:10. Explain what performance data is needed:11. Explain how the performance data demonstrates that the device is or is not substantially equivalent:

The performance data demonstrated that the subject device produces less wear than the predicate device.Please see Summary for more detailed information.

K040627/S2

INTERNAL ADMINISTRATIVE FORM:

YES NO 1. Did the firmrequest expedited review? X 2. Did we grant expedited review? N/A 3. Have you verified that the Document is labeled Class III for GMP purposes? X

4. If, not, has POS been notified? N/A 5. Is the product a device? X 6. Is the device exempt from 510(k) by regulation or policy? X

7. Is the device subject to review by CDRH? X 8. Are you aware that this device has been the subject of a previous NSE decision? X 9. If yes, does this new 510(k) address the NSE issue(s), (e.g., performance data)? N/A 10. Are you aware of the submitter being the subject of an integrity investigation? X 11. If, yes, consult the ODE Integrity Officer. N/A 12. Has the ODE Integrity Officer given permission to proceed with the review? (Blue Book N/A Memo #I91-2 and Federal Register 90N0332, September 10, 1991.

K040627/S2

(b) (1) (A)

510(k) REVIEW MEMORANDUM

To: K040627.S2From: Elizabeth Frank, Biomedical Engineer, M.S.

FDA/CDRHIODE/DGRND/Orthopedic Devices Branch (HFZ-410)

Date: August 3, 2005Device: DePuy ASRTM Modular Acetabular Cup System

Regulation Number: 21 CFR 888.3330Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component

prosthesisProduct Code: 87 KWA; Class III

Company: DePuy Orthopaedics, Inc.P.O. Box 988700 OrthopaedicsWarsaw, IN 46581-0988

Contact: Natalie Heck, Manager, Regulatory Affairs

Phone: 574-372-7469, Fax: 574-371-4939, Email: nheckidpn/us.ini.com Ck) La±. //

Recommendation: The intended use, material, and design features of the DePuy ASRTM Modular Acetabular Cup

System are Substantially Equivalent (SE) to the DePuy Pinnacle Metal-on-Metal Acetabular Cup Line (K002883,

K003523) and the Biomet M'aTM System (K993438, K002379, K003363, KOI 1110, K042037).

Review:

1. Administrative Requirements:The submission contains a 510(k) Summary, a Truthful and Accuracy Statement, Indications for Use page

and Class III Certification and Summary.

2. Device Description:

Acetabular Shell:The acetabular component is designed as a cast cobalt-chrome-molybdenum (CoCrMo) alloy (ASTM F-75)

one-piece cup with Porocoat® porous coating with the addition of a hydroxyapatite (HA) coating on the

outer surface. The acetabular shell has a highly polished, superfinished internal bearing surface, and is

available with outer diameter sizes 44-62 mm in 2mm increments with inner diameters ranging from 39-

55mm. There is no separate liner component to this system, as it is a one-piece acetabular shell used with a

unipolar femoral head and a taper sleeve adapter. The acetabular shell is identical to the

In Amendment 1, dated 8/1/05 the sponsor

has withdrawn the largest size components (57, 59, 61, and 63mm) from this submission.

The predicate DePuy Pinnacle metal-on-metal (MOM) system (K003523, K002883) is designed as a

wrought CoCrMo alloy (ASTM F-1537) superfinished metal liner that assembles into a porous coated,

titanium alloy metal shell. The titanium aluminum vanadium (Ti-6A1-4V) alloy acetabular cup is a

hemispherical stepped and porous-coated shell with three dome screw holes, an apical hole used for

visualization, and a peripheral female taper. The metal insert mechanically locks with the metal shell via a

taper junction. The Porocoat® porous coating on the shell is commercially pure titanium. The Pinnacle

MOM liner is available in 28 or 36mm inner diameter options, for use with corresponding 28 & 36mm

CoCrMo metal femoral heads.

K040627Pg. 1 of 30

(b) (1) (A)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

Porocoat Coating:The subject shell component uses the same PorocoatV process used for the predicate device (K002883 &

K003523). The coating consists of

Table 1 includes a summary of the properties of the PorocoatO porous

coating:

Hydroxyapatite Coating:The outer surface of the cup has the addition crystalline hydroxyapatite (HA) coating.

Characteristics of the HA coating on the CoCrMo Porocoat substrate are found in Master

The HA material conforms to ASTM F1185-88 for hydroxyapatite (Ca 5(PO4)30H) ceramic.

Given the crystalline nature of the HA coating and the strength of attachment to the porous surface, the

sponsor does not feel there is a well-developed mechanism of particulate release from the shell OD into the

periarticular tissue or synovial fluid to subsequently migrate into the articular surface.

In the situation where an HA particle would potentially be released from the acetabular shell and migrate

into the articular region, it would likely be very small in order to advance into the metal-on-metal articular

space (less than 80-190 microns, for ASR articular surfaces).

Alternatively, if the particle were larger than the clearance between the articular surfaces maintained by the

fluid film lubrication regime and became trapped within the articular surfaces under the circumstances of

microseparation, the sponsor believes that several things would occur:

* The very hard surfaces of the CoCrMo alloy would crush the weaker and brittle HA particle

creating much smaller sub-micron size particles allowing them to float freely out of the surface andbecome resorbed by the body fluids.

* If a larger HA particle were to scratch the articular surface, the sponsor believes it would be

fractured and washed free of the articular surfaces and the scratch would eventually repolish as

metal-on-metal heads are known to do.

From the known clinical experience and laboratory testing the sponsor does not believe that these particles

would cause degradation to the surface of the two hard, metal surfaces. We have previously allowed the

addition of HA coating to metal-on-metal acetabular shells, therefore since the sponsor has addressed this

concern, this is acceptable.

Femoral Head:The uni femoral head is manufactured from cast high carbon cobalt-chromium-molybdenum (CoCrMo)

alloy (ASTM F-75) and is available in a range of diameters from 39-55mm in 2mm increments. In

Amendment 1 dated 8/1/05, the sponsor has withdrawn the largest size components (57, 59, 61, and 63mm)

from this submission. All of the uni femoral heads have an internal taper, which mates with a CoCrMo taper

sleeve adapter specific to the 12/14 or 11/13 tapers corresponding to the external tapers on DePuy femoral

sterns. The femoral heads have a highly polished, superfinished exterior bearing surface, and articulate with

corresponding one-piece metal acetabular cups. The sponsor states that the material, outer diameter,

clearances and surface finishes of the

K040627Pg. 2 of 30

(b) (4)

(b) (4)

(b) (4)

(b) (4)

are identical to the subject unipolar femoral head. The predicate DePuy Pinnacle system

(K003523, K002883) is composed of wrought Co-Cr-Mo alloy (ASTM F-1537) and comes in sizes of 28 or

36mm.

The sponsor compares their femoral heads to the Wright Medical TRANSCEND Articulation System. Both

devices are supplied in large diameter sizes (subject device: 39-55mm and Wright: 38-54mm). Both

devices are manufactured from cast high carbon CoCrMo alloys conforming to ASTM specifications and

articulate with a one-piece CoCrMo alloy acetabular shell. Articulating surfaces of both the uni femoral

head and one-piece acetabular cup are super finished to ensure proper tolerances.

Taper Sleeve Adapters:The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The modularity

of using taper sleeve adapters in two taper options allows for a reduced number of femoral head

components while offering various femoral head offsets and compatibility with multiple femoral stems.

The ASR 12/14 taper sleeve adapters are manufactured from forged cobalt-chrome-molybdenum

(CoCrMo) alloy. The taper connections are based upon the design used for the adapter sleeves described in

the DePuy Ultima Unipolar Adapter Sleeves (K965156). The 12/14 taper sleeve adapters are offered in

neck length options of+l.5, +5, and +8.5. The 11/13 taper sleeve adapters are manufactured from wrought

CoCrMo alloy and were previously cleared in the Ultima Unipolar Head and Sleeve (K965156) and are

offered in neck length options of +0, +6, and +12.

A list of all sizes of the DePuy ASRTM Modular Acetabular System is included in Amendment 1 with a list

of compatible components in Exhibit 1. The sponsor states this is "a representative sample of taper adapter

sleeve and femoral stem compatible components for the DePuy ASR TM Modular Acetabular System, and

should not be taken as a complete listing. Femoral stem compatible components are limited to stems

manufactured of Cobalt Chrome Molybdenum alloy or Titanium alloy, and having taper sizes of 11/13 or

12/14. This limitation corresponds to the listed taper sleeve adapted styles manufactured from Cobalt

Chrome alloy. Device photographs are included on page 13 and engineering drawings are provided in

Exhibit 2. The taper sleeve adapter drawings are included on page 13 of Supplement 1.

Material:The subject system is composed of cast high carbon cobalt-chromium-molybdenum (CoCrMo) alloy

(ASTM F-75). ASTM F-75 requires the carbon content of the CoCrMo casting alloy material be within the

range of 0-35%. The internal material specification for the subject ASRTM uni femoral head and cup

specifies a carbon content within the range of Adherence to this internal specification

guarantees the device will have a carbon content within the of the range required by the

ASTM specification.

The sponsor believes material combination (wrought or cast) is insignificant providing the conditions of

elastohydrodynamic lubrication have been achieved through the design parameters of surface finish, form,

diametrical clearance and the use of large diameter heads. Test Report RDR 143/02 (Exhibit 4, Index 3)

details the work done to compare

The internal raw material specification for the wrought CoCrMo alloy requires a carbon content in the range

of The carbon content of the cast CoCrMo alloy is specified to a

of the ASTM specification.

Based on the carbon content requirements and testing performed, the sponsor concludes that there is no

increase in safety concerns based upon the change from wrought CoCrMo to cast CoCrMo for the ASR uni

head and cup bearing couple.

Diametrical Clearances:The diametrical clearances for all femoral implants (femoral heads to acetabular cups) are provided in Table

2 below. The sponsor has withdrawn the largest size components (57, 59, 61, and 63mm) from this

submission, so they were removed from the following table.

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Table 2. Diametrical Clearances

In Supplement 2, the sponsor has provided a comparison table (Table 3) of previously cleared diametrical

clearances. The first DePuy Metal-on-Metal Hip System was the Ultima® Metal-On-Metal Acetabular Cup

(28mm) cleared in K001523.

. In Exhibit 4 of K002883, the sponsor provides a comparison chart identifying that the

diametrical clearance for the predicate Ultima and the 28mm Pinnacle system are identical, ranging from

40-80pm.

In K003523, the Pinnacle system was expanded to include 36mm liners. The comparison chart of the

28mm and 36mm Pinnacle liners (K003523, Exhibit 4) indicates the 28mm and 36mm liners have identical

diametrical clearances (40-80pm). However, the sponsor has indicated in the subject submission that the

36mm liners have a . On 7/12/05 the sponsor was contacted by telephone to clarify

the diametrical clearance of the 36mm system. The sponsor discovered the chart in Exhibit 4 of the

predicate device is incorrect. According to the engineering drawings of K003523 the Pinnacle 36mm

system has a

According to current practices in ORDB the diametrical clearance of a system cannot be changed without

clinical data. Therefore, given this new information the Pinnacle 36mm system may not have been cleared

in 2000. However, after searching the Medical Device Reporting Program (MDRs) for adverse events

associated with the Pinnacle 36mm liners, only 5 adverse events were reported. Three of these adverse

events were failure for the liner and shell to line up appropriately, one adverse event was a patient revised

due to pain and one adverse event gave no details. Over the same period of time, the comparable Sulzer

metal-on-metal system had approximately 25 adverse events reported, while Zimmer had 3 reports

regarding the 28mm acetabular insert and 3 reports regarding their Cobalt Chrome femoral head.

Therefore, during the same time period the 36mm Pinnacle system had a reasonable number of adverse

events reported.

Table 3. Diametrical Clearances of Previously Cleared Systems

The technical justification for increasing the clearance above that of the predicate Pinnacle Metal-on-Metal

design has been described in test report RDR117/04, from Supplement 1. Modem metal-on-metal

hip implants have a fluid film lubrication where a thin layer of lubricant completely separates the head and

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cup bearing surfaces thus protecting the articulating surfaces during relative motion and reducing wear. For

this reason, it is important to optimize the clearance to ensure that the bearing receives adequate lubrication

for wear reduction. Based on the

there is no increase in safety concerns based upon the increase in diametrical clearance.

Predicate Device Comparison:

The Biomet M2a M 28mm Acetabular System (K993438) had clinical data to support its safety and

effectiveness when it was originally cleared. The system was expanded to include 32mm liners (K002379)

without clinical data. Both sizes were composed of CoCrMo per ASTM F1537, with the same tolerance

bands and clearance between the modular heads and liners. In KO11110, the M2 aTM System was expanded

to include 38mm components. The 38mm acetabular cup and modular heads are composed of CoCrMo per

ASTM F75. The wear test for the 38mm components tested minimum and maximum diametrical clearance

(55-167 kim) to ensure the worst case was evaluated. The sponsor states clearances and sphericities were

slightly different than the 32mm components, but the clearances were not clearly identified in the predicate

device, so it is difficult to make a direct comparison. Clinical data was not provided for the change in

material, diameter or clearance because the reviewer believed the changes could be addressed through

mechanical testing. The only testing completed was wear testing for 5.5 million cycles. Biomet's next

submission for the M2a Magnum System (K042037) increased diameter from 38mm to 40mm-60mm.

These components are also composed of ASTM F75. Wear testing was completed and a range of

clearances from 106-494 gm was evaluated. Since larger diameters have lower wear rates no concerns were

found with increasing diameter or altering diametrical clearances.

The sponsor explains that increasing the bearing diameter enhances the wear performance of a metal-on-

metal articulation because elastohydrodynamic lubrication is more easily achieved. Therefore, the larger

ASR bearing diameters represent a better wear scenario than the predicate 36mm Pinnacle Metal-on-Metal

Acetabular Cup System. Additionally, larger diameter heads offer greater resistance to subluxation and

dislocation as well as improved range of motion.

Test report RDR 117/04

The sponsor was asked to provide more information regarding the

On 7/21/05 an "Engineering Rounds" discussion was held to discuss changes in metal-on-metal hip systems

that may or may not require new clinical data. We discussed this file and the Wright Medical

CONSERVE® Total Femoral Head (K051348, under review). Based on the changes that have previously

been allowed with mechanical testing according to the Biomet description above, the proposed DePuy

changes are comparable. The sponsor addressed our final concern regarding frictional torque of the largest

size components by withdrawing the components over 55mm that were not evaluated. Please see the

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attached summary of the Engineering Rounds discussion. Tables 4 and 5 summarize the similarities and

differences between the subject and predicate devices.

3. Intended Use:The DePuy ASRTm Modular Acetabular Cup System is indicated for use in total hip replacement procedures

for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid

arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of

femoral fractures. Use of prosthesis is also indicated for patients with congenital hip dysplasia, slipped

capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other

reconstruction techniques.

The indications for use statement is the same as the Pinnacle Metal-On-Metal Acetabular Cup Liner

(K003523), except it has been revised from the acetabular component in total hip replacement to the entire

total hip replacement.

4. Sterilization:Radiation Type: GammaRadiation Source: Minimum Dosage: Sterility Assurance Level: Sterility Validation Method:

5. Labeling:The instructions for use and draft labels are provided in Exhibit 3. The package labels contain the

appropriate information. The package insert for the DePuy ASR® Modular Acetabular Cup System

contains all appropriate information (device description, indications, contraindications, potential adverse

events, warnings and precautions, cleaning and sterilization information). The sponsor also includes the

Instructions for Use of the previously cleared Ultima Unipolar Taper Sleeve.

K040627Pg. 6 of 30

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6. Testing:Many of the test reports were performed and these results are being used

to support the articulation of the large diameter unipolar femoral heads and ASR acetabular cups in the

subject submission. Hip joint replacement devices transmit load through the bearing surface, specifically

the joint contact area. This is no difference whether the femoral component takes the form of a modular

head and femoral stem or a In laboratory testing simulation, the loading in the

contact area is affected by components of the bearing design, specifically bearing size, clearance, surface

roughness and Young's modulus of the bearing material, but not by the method of fixation of the femoral

This is acceptable.

1. Testing:

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2. Testing:

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4b: Test Data

Title: Analysis of Fluid Film Lubrication in Artificial Hip Jiont Replacements with Surfaces of High Elastic Modulus Author(s): Z M Jin; D Dowson; 3 Fisher Source: Proceedings of the I MECH E Part H Journal of Engineering in Medicine Volume: 211 Page: 247-256 Abstract: Lubrication mechanisms and contact mechanics have been analyzed for total hip joint replacements made from hard bearing surfaces such as metal-on-metal and ceramic-on-ceramic. A similar analysis for ultra-high molecular weight polyethylene (UHMWPE) against a hard bearing surface has also been carried out and used as a reference. The most important factor influencing the predicted lubricating film thickness has been found to be the radial clearance between the ball and the socket. Full fluid film lubrication may be achieved in these hard/hard bearings provided that the surface finish of the bearing surface and the radial clearance are chosen correctly and maintained. Furthermore, there is a close relation between the predicted contact half width and the predicted lubricating film thickness. Therefore, it is important to analyze the contact mechanics in artificial hip joint replacements.

Title: The effect of femoral head diameter upon lubrication and wear of metal-on-metal total hip replacements Author(s): S L Smith; D Dowson; A A J Goldsmith Source: Proceedings of the I MECH E Part H Journal of Engineering in Medicine Volume: 215 Page: 161-170 Abstract: It has been found that a remarkable reduction in the wear of metal-on-metal hip joints can be

achieved by simply increasing the diameter of the joint. A tribological evaluation of metal-on-metal joints of 16, 22.225, 28 and 36 mm diameter was conducted in 25 percent bovine serum using a hip joint simulator. The joints were subject to dynamic motion and loading cycles simulating walking for both lubrication and wear studies. For each size of joint in the lubrication study, an electrical resistivity technique was used to

detect the extent of surface separation through a complete walking cycle. Wear of each size of joint was measured gravimetrically in wear tests of at least 2x106 cycles duration. Joints of 16 and 22.225 nun diameter showed no surface separation in the lubrication study. This suggested that wear would be proportional to the sliding distance and hence joint size in this boundary lubrication regime. A 28mm diameter joint showed only limited evidence of surface separation suggesting that these joints were operating in a mixed lubrication regime. A 36 mm diameter joint showed surface separation for considerable parts of each walking cycle and hence evidence of the formation of a protective lubrication film.

Wear testing of 16 and 22.225 nun diameter metal-on-metal joints gave mean wear rates of 4.85 and 6.30 6mm3 /I10 cycles respectively. The ratio of these wear rates, 0.77, is approximately the same as the joint

diameters ratio, 16/22.225 or 0.72, as expected from simple wear theory for dry or boundary lubrication conditions. No bedding-in was observed with these smaller diameter joints. For the 28 nun diameter joint, from 0 to 2xI06 cycles, the mean wear rate was 1.62 MM3 /106 cycles as the joints bedded-in. Following bedding in, from 2.Ox106 to 4.7x1 06 cycles, the wear rate was 0.54 mm~/10 6 cycles. As reported previously by Goldsmith et al. in 2000, the mean steady state wear rate of the 36 mm diameter joints was lower than those of all the other diameters at 0.07 mm3 /106 cycles. For a range of joints of various diameters, subjected

to identical test conditions, mean wear rates differed by almost two orders of magnitude. This study was demonstrated that the application of sound tribological principles to prosthetic design can reduce the wear of metal-on-metal joints, using currently available materials, to a negligible level.

8. Sponsor's Information in support of SE: DePuy Pinnacle Metal-on-Metal Acetabular Cup Liner (K003523, K002883) Wright Medical Metal TRANSCEND® Articulation System (K02 1349) DePuy Ultima Unipolar Head and Adapter Sleeves (K965 156)

9. Review of other 5lO(k)s/IDEs: Wright Medical Metal TRANSCEND® Articulation System (K004043/SOO I) Corin USA Cormet Large Diameter Metal on Metal Hip System IDE (0030265)

K040627 Page 28 of31

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Biomet M2a TM Acetabular System (K993438, K002379, K003363, KOI 11I10, K042037)

10. Summary:The acetabular component of the ASRm Modular Acetabular Cup System is designed as a cast cobalt-

chrome-molybdenum (CoCrMo) alloy (ASTM F-75) one-piece cup with Porocoat® porous coating with theaddition of a hydroxyapatite (HA) coating on the outer surface. The acetabular shell is available with outerdiameter sizes 44-62 tur in 2mm increments with inner diameters ranging from 39-55mm. The uni femoralhead is manufactured from cast high carbon cobalt-chromium-molybdenumn (CoCrMo) alloy (ASTM F-75)and is available in a range of diameters from 39-55mm in 2mm increments. All of the uni femoral headshave an internal taper, which mates with a CoCrMo taper sleeve adapter specific to the 12/14 or 11/13tapers corresponding to the external tapers on DePuy femoral stems.

The ASRTm Modular Acetabular Cup System is a newly designed metal-on-metal hip system with largerdiameters, a different form of Co-Cr-Mo and larger diametrical clearances than their predicate Pinnaclesystem (K003523, K002883). They have developed a system that produces less wear than their ownpreviously cleared Pinnacle metal-on-metal system, which had clinical data supporting its safety and

previously cleared metal-on-metal systems that may or may not have been supported with clinical data,please see Tables 4 and 5.

ORDB has been particularly careful in regards to what changes have been allowed for metal-on-metalsystems with and without the support of clinical data. Review of several predicate systems revealed that wehad allowed more significant changes than realized. For example, in K003523, the Pinnacle system wasexpanded to include 36mm liners. The comparison chart of the 28mm and 36mm Pinnacle liners

(K003523, Exhibit 4) indicates the 28mm and 36mm liners have identical diametrical clearances (40-80gm). However, the sponsor has indicated in the subject submission that the 36mm liners have a clearanceof 80-120gim. On 7/12/05 the sponsor was contacted by telephone to clarify the diametrical clearance ofthe 36mm system. The sponsor discovered the chart in Exhibit 4 of the predicate device is incorrect.According to the engineering drawings of K003523 the Pinnacle 36mm system has a diametrical clearanceof 80-120pm.

After this information was realized a search of the Medical Device Reporting Program (MDRs) for adverse

events associated with the Pinnacle 36mm liners was completed. For the Pinnacle 36mm liners only 5adverse events were reported. Three of these adverse events were failure for the liner and shell to line upappropriately, one adverse event was a patient revised due to pain and one adverse event gave no details.Over the same period of time, the comparable Sulzer metal-on-metal system had approximately 25 adverseevents reported, while Zinimer had 3 reports regarding the 28mm acetabular insert and 3 reports regardingtheft Cobalt Chrome femoral head. Therefore, during the same time period the 36mm Pinnacle system hada reasonable number of adverse events reported.

Another example of various changes made to metal-on-metal systems without the support of clinical data isthe Biomet M2aTM System. The Biomet M2aTM 28mm Acetabular System (K993438) had clinical data tosupport its safety and effectiveness when it was originally cleared. The system was expanded to include32mm liners (K002379) without clinical data. Both sizes were composed of CoCrMo per ASTM F 1537,with the same tolerance bands and clearance between the modular heads and liners. In K0l11110, theM2a TMSystem was expanded to include 38mm components. The 38mm acetabular cup and modular headsare composed of CoCrMo per ASTM F75. The wear test for the 38mm components tested minimum andmaximum diametrical clearance (55-167 gin) to ensure the worst case was evaluated. The sponsor statesclearances and sphericities were slightly different than the 32mm components, but the clearances were not

K040627Page 29 of 31

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clearly identified in the predicate device, so it is difficult to make a direct comparison. Clinical data was

not provided for the change in material, diameter or clearance because the reviewer believed the changes

could be addressed through mechanical testing. The only testing completed was wear testing for 5.5 millioncycles. Biomet's next submission for the M2a Magnum System (K042037) increased diameter from 38mmto 4Omm-6Omm. These components are also composed of ASTM F75. Wear testing was completed and arange of clearances from 106-494 pim was evaluated. Since larger diameters have lower wear rates no

concerns were found with increasing diameter or altering diametrical clearances.

In the subject submission, the sponsor has completed , however, the largest size

On 7/21/05 an "Engineering Rounds" discussion was held to discuss changes in metal-on-metal hip systems

that may or may not require new clinical data. We discussed this file and the Wright Medical

CONSERVE® Total Femoral Head (KO5 1348, under review). Based on the changes that have previouslybeen allowed with mechanical testing according to the Biomnet description above, the proposed DePuy

changes are comparable. The sponsor addressed our final concern regardin

Therefore, the sponsor has adequately addressed our concerns regarding the changes in diameter, clearance

and material from their own previously cleared Pinnacle System, which was supported by clinical data. Theintended use, material, and design features of the DePuy ASR~m Modular Acetabular Cup System are

Substantially Equivalent (SE) to the DePuy Pinnacle Metal-on-Metal Acetabular Cup Line (K(002883, K003523)

and the Biomet M2aTM System (K993438, K(002379, K003363, KOI011I10, K(042037).

1. Contact History/Requests for More Information:5/14/04 - Spoke with Natalie Heck to discuss design and to confirm that this is a new system.

6/3/04 - Sponsor was sent an Al letter requesting more information on this systemn.7/2/04 - Sponsor requested additional time for response through DMC

7/29/04 - Sponsor requested additional time for response through DMC1 1/3 0/04 - Natalie Heck left a message, they are getting ready to submit response and have some questions

- They have done more testing on resurfacing system- Asked if there were any particular concerns with instructions for use, none that I recall

12/6/04 - Received document off of hold1/10/05 - Joint team recommends clinical data1/18/05 - Mark Melkerson, DGRND Deputy Director, and Ted Stevens, REDB3 Chief, recommend clinical

data at 5 10(k) rounds1/26/05 -File placed on hold, sponsor sent a deficiency letter requesting clinical data.

2/4/05 - Natalie Heck requested a face-to-face meeting to discuss our request for clinical data- Mike Courtney set up meetings: Pre-meeting Eni, 2/11 at I PM 020H, Sponsor meeting Thurs,

2/17 at 3PM 020H2/8/05 - Natalie Heck called and canceled 2/17 meeting

- Mike Courtney rescheduled for 3/3 at 2:30 PM- Sponsor cannot make time, Mike Courtney will attempt to reschedule again

2/10/05 - Sponsor reinstated 2/17 meeting from 3-4PM2/11/05 - Left Natalie Heck a message asking if there is anything not in the letter that they would like to

discuss during pre-meeting

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2/16/05 - Received agenda for meeting and passed out to attendees2/17/05 - Industry meeting, please see meeting minutes3/1/05 - Natalie Heck requested one week extension

- Referred her to Guidance Document that 30 Day timeftame is not strictly enforced, but she

should request additional time, as soon as they decide course of action3/4/05 - Natalie Heck called, they are going to pursue the 5 10(k) without clinical data

-The sponsor will submit a supplement to the existing 5 10(k)-The sponsor will request a 90 day extension through DMC

3/7/05 - Received email copy of letter that the sponsor is sending to DMC requesting 90 Day Extension3/16/05 - Mike Courtney wrote meeting minutes, I agree with them5/17/05 - Natalie Heck called to say they would like to include an overview document and then address

each question specifically, I told her that should be fine assuming each question is directlyaddressed

- The sponsor anticipates responding by 5/24

5/25/05 - Received Supplement 27/12/05 - Sponsor's response for predicate 3 6mm lists wrong clearances, predicate says identical

clearances (K003523)- Called sponsor, the predicate chart is incorrect predicate clearances were changed- Metal-on-Metals Hips is a good topic for Engineering Rounds, scheduled for Wed., 7/20

7/20/05 - Took document to Joint Team to discuss that many predicates have actually changed diametricalclearances

- Engineering Rounds - see minutes, don' t need clinical data for changes, but we are concernedabout the largest components

- Left Natalie Heck a message that we want to know more about 7/22/05 - Called Natalie Heck to discuss large diameter heads and asked them to provide a rationale for

only completing - The sponsor will consider - As for predicate 36mm Pinnacle (1K003523), they will submit an add to file to explain that

predicate comparison table was inaccurate7/29/05 - Natalie Heck called to discuss with Rebecca Lennard, Project

Engineer- S1, Q5 response includes equation and estimated range for all sizes- I asked sponsor to see the actual calculations for the estimations of of the larger

size components and asked how clearance play a role since the results indicate a larger clearancehas

- Natalie Heck left me a message that they would be willing to test larger sizes, but since that will

take time, - I left the sponsor a message saying it is fine if they want to , please

fax something to me8/1/05 - Natalie Heck emailed meto say shechas not been able to fax me the document, she has Fed Exed

a hard copy and emailed me an electronic version8/2/05 - Received hard copy of Amendment 1

Eli eth L. Frank, M.S. (Date)Orthopedic Devices BranchDivision of General, Restorative and Neurological Devices

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K040627 - Supplement 1:Original Deficiencies (with sponsor responses):

1.The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composed of Cast HighCarbon Co-Cr-Mo alloy (ASTM F-75), white your predicate Pinnacle TM Metal-on-Metal Acetabular Cup(K003523 & K002883) is composed of Wrought Co-Cr-Mo alloy (ASTM F-1537). l

.

Report RDRO45/03 summarizes the

The sponsor concludes from the testing performed that there is no increase in safety concerns based uponthe change from or the ASR Uni head and cup bearing couple. The sponsorhas included several supporting references.

Although the Wright Medical TRANSCEND® Articulation System (K02 1349) is composed of Cast Co-Cr-Mo alloy (ASTM F-75), this system had its own clearances and tolerances, which were proven to be safeand effective through their own clinical data. Your diametrical clearances and tolerances have not beenidentified in your submission.

The predicate Pinnacle metal on metal system had clearances ranging from . In support of thediametrical clearances defined, PDT 117/04,

report was performed using , the results are being used to support thearticulation of the large diameter unipolar femoral heads and ASP acetabular cups that are part of the

subject DePuy ASPRModular Acetabular Cup System 510(k) submission. DePuy believes that

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All of these design differences can significantly influence the clinical outcomes for metal-on-metal hiparthroplasty devices. These changes present safety concerns that we feel cannot be addressed by preclinicaltesting and must be addressed by clinical data to support a determination of substantial equivalence of your510(k). If the clinical data are collected in the US, the clinical data would need to be collected as part of a

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FDA-approved investigational device exemption (IDE) application. We recommend that you contact usprior to submission of an IDE to address any questions related to the clinical study design.

The sponsor has not adequately addressed our concerns regarding the The sponsor will be asked to provide clinical data.

2. The test reports submitted in Exhibit 4 refer to a ). Please clarify which components of this system are identical to the components

in the resurfacing IDE study and which are unique to this submission.

•

*

•

Please complete approriate on the worst-case scenario for the components in thissubmission or provide an . Pleasejustify your choice for the worst case femoral headl/acetabular cup construct (e.g. most likely the 63ramhead and cup).

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3. The submission states, "The modularity of using taper sleeve adapters in two taper options allow for areduced number of femoral head components while offering various femoral head offsets and compatibilitywith multiple femoral stems." The size of the femoral head can affect the fatigue strength of the femoral

stem in vivo.

It is not the size of the femoral head that affects the fatigue strength of the femoral stem, but rather thefemoral head offset. Typical stem fatigue testing is performed with the worst-case offset,

4. The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The taper sleeveadapter results in a somewhat hollow head design which may be susceptible to additional failure modes(i.e. fatigue fracture involving the cylindrical shaft in which the Sleeve Adapter fits) that a solid head wouldnot encounter. We believe , to assess the strength of the cylindrical sleeve adapter shaft, isnecessary to establish the safety and effectiveness of the device. Please provide an

Please see test report RDR063/04

5. The test reports included in Exhibit 4 address . In addition to have been known to cause component

. Therefore, we believe the is an important

parameter in assessing the safety and effectiveness of a metal-on-metal hip system. Please provide both before and after the

devices undergo

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The sponsor will be sent a letter requesting additional information with the followingDeficiencies:

1. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composed of Cast High Carbon

Co-Cr-Mo alloy (ASTM F-75), with diametrical clearances of microns and sizes ranging from 39-63mm. Your predicate Pinnacle TM Metal-on-Metal Acetabular Cup (K003523, K002883) is composed ofWrought Co-Cr-Mo alloy (ASTM F-1537), with diametrical clearances between and diametersof 28 or 36mm.

d


b. The diametrical clearances and tolerances provided in Supplement 1 range from microns with a


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Based on our concerns regarding the changes in we believeclinical data are necessary to support a new metal-on- metal system. If the clinical data are collected in theUS, the clinical data would need to be collected as part of a FDA-approved investigational deviceexemption (IDE) application. We recommend that you contact us prior to submission of an IDE to addressany questions related to the clinical study design.

2. Several of the provided test reports were performed using and these results arebeing used to support the articulation of the large diameter unipolar femoral heads and ASR acetabular cups inthe subject submission.

systems are evaluated as an entire assembly. Differences between the will affect the loading of the system, as well as wear patterns. We do not believe that

preclinical testing of a can be appropriately substituted as preclinical testing for a total hip

system. Therefore the following reports submitted in Supplement 1 are not considered to be applicable to thissubmission and the original deficiencies referencing these reports remain:

* RDR 151/03 -

• RDR 117/04 -

*

•

*In addition, please recognize that the used in this test report is .

3. In response to Question 5, you have submitted data on theresurfacing components of this system. As described above, we do not believe preclinical testing of

provide comparable results, due to differences in in vivo loading conditions. Therefore,the original deficiency remains and both rotational and flexion/extension frictional torque data on the total hipsystem is requested. In addition, the provided lever-out testing for the acetabular cup does not address ourconcerns regarding rotati

4. The proposed acetabular component is a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup withPorocoat® porous coating with the addition of DuoFix hydroxyapatite (HA) coating on the outer surface. Yourpreviously cleared Pinnacle metal-on-metal (MOM) acetabular cup is designed as a wrought CoCrMosuperfinished metal liner that assembles into a porous coated, titanium alloy metal shell. We have concerns

a.

b.

K040627/S 1 - Deficiency ResponsesPg. 6

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K040627 - Supplement 2:Supplement 1 Deficiencies (with sponsor responses):

1. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composed of Cast High

Carbon Co-Cr-Mo alloy (ASTM F-75), with diametrical clearances of microns and sizes

ranging from 39-63mm. Your predicate Pinnacle Metal-on-Metal Acetabular Cup (K003523,

K002883) is composed of Wrought Co-Cr-Mo alloy (ASTM F-1537), with diametrical clearances

b microns and diameters of 28 or 36mm. The

each testing:

a. In Supplement 1, you referenced a previously submitted he

ASTM F75 requires that the carbon content of the cobalt chromium molybdenum (CoCrMo)

casting alloy material be within the range of 0-.35%. The internal raw material specification for

the subject ASRTM unifemoral head and cup specifies a carbon content within the range A copy of the internal raw material specification IRM 103-21-001 is provided in the

rationale and technical overview. Adherence to this internal specification guarantees the devicewill have a carbon content within the of the range required by the ASTM

specification. This range also fits the specifications of ASTM F1537 (Alloy 2 - High Carbon),

which specifies a range of 0.15-0.35%.

As described in the rationale and technical overview, the material combination (wrought or cast)

is insignificant providing the conditions of elastohydrodynamic lubrication have been achieved

through the design parameters of surface finish, form, diametrical clearance and the use of large

diameter heads. Please refer to RDR 143/02 (Exhibit 4, Index item 3 "Hip Simulator, "K040627).

This report details the work done to compare the wear performance of the wrought and cast

material combinations using the previously cleared 36mm DePuy Pinnacle Metal on Metal

Acetabular Cup design (K003523). The internal raw material specification for the wrought

CoCrMo alloy requires a carbon content in the range of The carbon content of

the cast CoCrMo alloy is specified to a tighter tolerance than that of the wrought material thus

ensuring adherence consistently in the specification. The results

demonstrate that there is not a statistical difference between the wrought and cast high carbon

material combinations.

Based on the carbon content requirements and testing performed, the sponsor believes that there

is no increase in safety concerns based upon the change from wrought CoCrMo to cast CoCrMo

for the ASR uni head and cup bearing couple.

b. The diametrical clearances and tolerances provided in Supplement 1 range from


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The sponsor notes that the stated predicate Pinnacle Metal-on-Metal Acetabular Cup systemclearance range in the deficiency letter requires correction. The minimum and maximum

clearances (microns) for the cleared metal-on-metal systems and the ASP modular system aresummarized in the table below.

memo.

Based on the bearing design and the performed, the sponsor does not believe there is

an increase in safety concerns based upon the increase in diametrical clearance.

c. The proposed DePuy ASR Unit Femoral Head and Acetabualar Cup System has diameters ranging

Based on our concerns believe clinical data are necessary to support a new metal-on- metal system. If the clinical data arecollected in the US, the clinical data would need to be collected as part of a FDA-approvedinvestigational device exemption (IDE) application. We recommend that you contact us prior tosubmission of an IDE to address any questions related to the clinical study design


Cd.

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The sponsor concludes from the analyses performed that there is no increase in safety concernsbased upon the larger head diameters of the subject device as compared to the predicate device.

2. Several of the provided test reports were performed using and theseresults are being used to support the articulation of the large diameter unipolar femoral heads and ASRacetabular cups in the subject submission. In Supplement 1 in response to question 2b, you state that

While thearticulating surfaces may be identical, hip systems are evaluated as an entire assembly. Differencesbetween the head will affect the loading of the system,as well as wear patterns. We do not believe that preclinical testing of a can beappropriately substituted as preclinical testing for a total hip system. Therefore the following reportssubmitted in Supplement 1 are not considered to be applicable to this submission and the originaldeficiencies referencing these reports remain:

* RDR 15 1/03 -

*

*

•

*In addition, please recognize that the used in this test report is currently under.

By the nature of their design, hip joint replacement devices transmit load through the bearing surface,specifically the joint contact area. This is no different whether the femoral component takes the form

In laboratory testing simulation,

fi~


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3. In response to Question 5, you have submitted data onthe of this system. As described above, we do not believe preclinical testingof provide comparable results, due to differences in in vivoloading conditions. Therefore, the original deficiency

In addition, the provided for the acetabular cup does not address our concerns regarding

.

Please see the response above (Question 2) regarding testing the versus the totalhip system. was performed and a copy of the completetest report is provided in Exhibit !. Please see belowfor a summary of the testing.


,SD

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4. The proposed acetabular component is a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cupwith PorocoatR porous coating with the addition of DuoFix hydroxyapatite (HA) coating on the outersurface. Your previously cleared Pinnacle metal-on-metal (MOM) acetabular cup is designed as awrought CoCrMo superfinished metal liner that assembles into a porous coated, titanium alloy metal

The DePuy ASRTM Modular Acetabular Cup System is comprised of a one-piece metal acetabularcup, a unipolarfemoral head, and a taper sleeve adapter.

The acetabular consists of a cobalt-chromium molybdenum (CoCrMo) alloy one-piece cupwith Porocoat® porous coating. The outer porous coated surface of the cup has the additionof a hydroxyapatite (HA) coating. There are no separate liner components to this system, asthe liners are integral to the one-piece acetabular cups.

The uni-femoral head is manufactured from cobalt-chromium molybdenum (CoCrMo) alloy.The unifemoral heads have an internal taper mates with a taper sleeve adapter. The femoralheads articulate with the corresponding one-piece metal acetabular cups. The sponsor ischanging from a liner and shell to a monoblock acetabular shell.

The taper sleeve adapters are manufactured from cobalt-chromium molybdenum (Co CrMo)alloy.

The DePuy PinnacleTm Metal-On-Metal (MOM) Acetabular Cup System is comprised of a metalacetabular shell, a metal acetabular cup insert, and modular metal femoral heads.

The outer titanium aluminum vanadium ri-A1-4V) alloy acetabular cup is a hemisphericalstepped and porous-coated shell with three dome screw holes, an apical hole used forvisualization, and a peripheral female taper. The Porocoat®D porous coating on the shell iscommercially pure titanium.

The superfinished metal liner is manufacturedlfrom cobalt-chromium molybdenum (CoCrMo)alloy. The metal insert mechanically locks with the metal shell via ataper junction.

The modular heads are superfinished cobalt-chromium molybdenum (CoCrMo) alloy metalfemoral heads. The metal femoral heads M-specification Articul/eze® cobalt-chromiummolybdenum (CoCrMo) alloy femoral heads with a 12/114 (A4rticul/eze) internal taper, and 5-ROM® M-Specification cobalt-chromium molybdenum (Co CrMo) alloy femoral heads with a11/13 internal taper.

K040627/S2 - Deficiency Responses

Pg. 6

As there are no separateshell/liner components to the ASR system, the requested comparison of

the shell/liner assembly/disassembly forces and the shell/liner locking mechanism is not

applicable.

b. Preclinical and clinical data addressing concerns associated with wear and fixation due to the

presence of HA coating or HA particulates and debris.

Given the crystallinenature of the HA coatingand the strength of attachmentto the porous

surface, the sponsor does notfeel there is a well-developed mechanism ofparticulatereleasefrom the shell OD into the periarticulartissue or synovialfluid to subsequently migrateinto the

articularsurface. Thesponsorisnotawareofthisphenomenonoccurringintheclinicalsetting for HA coated metal-on-metalcouples or HA coated metal-on-polyethylene couples.

In the situation where an HA particlewould potentiallybe releasedfrom the acetabularshell and

migrate into the articularregion, it would likely be very small in order to advance into the metal-

on-metal articularspace (less than 80-190 microns,for ASR articularsurfaces). The potential

exists for the smallerparticleto pass through the articularregion, neither imbedding nor scratchingthe articularsurface.

Alternatively, if the particlewere larger than the clearancebetween the articularsurfaces

maintainedby thefluidfilm lubrication regime and became trapped within the articularsurfaces

under the circumstancesofmicroseparation,the sponsorbelieves that severalthings would occur:

* The very hardsurfaces of the CoCrMo alloy would crush the weaker and brittleHA

particlecreatingmuch smallersub-micron size particlesallowing them tofloatfreely out of the surfaceand become resorbedby the bodyfluids.

l If a largerHA particlewere to scratch the articularsurface, the sponsor believes it would be fracturedand washedfree of the articularsurfaces and the scratch would

eventually repolish as metal-on-metalheads areknown to do.

From the known clinicalexperience andlaboratorytesting the sponsordoes not believe that these

particles would cause degradationto the surface of the two hard, metal surfaces. HA coatings

have previously been allowed on metal-on-metal systems. The sponsor has acknowledged the

concerns associatedwith an HA coating on a hard-on-hardarticulation,this is acceptable.

K040627/S2 - Deficiency Responses Pg. 7

(b) (4)

(b) (4)

Frank, Elizabeth L

From: Peck, Jonathan H,nt: Wednesday, July 20, 2005 4:42 PM

Frank, Elizabeth L; Melkerson, Mark N.; Stiegman, Glenn A; Horbowyj, Roxolana;Gantenberg, Julie *; Allen, Peter; Demian, Hany; Holden, John P; Hanafi, Nada 0; Rossi,Jeffrey; Janda, Michel D; Marjenin, Timothy A*

Subject: Engineering Rounds Summary

First of all, thank you to Beth for her extensive preparation that led to a very productive discussion. And thank you all for

coming.

Since this was sort of a policy setting meeting, I wanted to try to document just a little bit of what we talked about/agreed

upon at the meeting. Please let me know if you think any of this needs to be changed.

We discussed both of Beth's files:

1.

2. The second file involved several changes. The company is also proposing a material change from Cast CoCr

to Wrought CoCr ( They also propose larger head sizes

which result in changes in clearance. The company provided side by side wear testing and frictional torque

data.

Again, the general consensus seemed to be that given the amount and compelling nature of preclinicalinformation supplied, that these changes would be acceptable to cleared.

,nathan Peckxchanical Engineer

FDA/CDRH/ODE/DGRND/Orthopedic Devices Branch9200 Corporate Boulevard, HFZ-410

3

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Memorandum of Meeting Minutes

S nsor: De u"Device Name: ASR Modular Hip

Meetin Date: 2/17/05Metin Tme and Location: 9200Corporate Blvd. 3:00 P.M.

A lication Number (if a licable): 1040627Sponsor Attendees: Steve Peoples, V.P. FDA Attendees: Beth Frank, Lead VReviewer,

Clin/Reg Affairs, Depuy; Robert O'Holla, Mark Melkerson, Dep. Dir./DGRND; John

V.P. Reg Affairs, J&J; Natalie Heck, Mgr. Hodn cigB..OD;Jh roodeSr

Reg. Afft, Depuy; Marlene Tandy, Sr. Reviewer/ORDB; Michael Courtney, Projec

Counsel, J&J; Rebecca Lennard, Hip Mgr./ORDB

R&D, Depuy; Todd Smith, Dir. Materials

Research, Depu iouotesosrrgrigorrqeP3urpose of Meeting: To discuss and provide clarificatintthspsoreadgourqet

for additional information dated January 26, 2005 for K040627

Su lement 1.

* MO, (mtalon mtal)is lass III Pre-amendments device. May in the future call for

•

*

Points of Concurrence* More prudent to seek smaller changes rather than several major changes at one time.

Burden is on the company to rationalize multiple changes at one time.

* Why bad designs are bad and good designs good is not clearly understood.

* FDA cannot extrapolate fluid film thickness tovaitearrclrnes

Unresolved issues:* What is good/bad design in relation to clearances?

* How to address the window compared to predicates?

* Are loading patterns the same for same diameters with different angulations?

* Needs to address HA w/hard on hard articulation

* What changes have taken place after initial design such as clearances, diameter, outer shell,

materials, geometry, etc?

* Material change does not just depend on carbon content, processing and manufacturing

also effect final product - therefore rely on clinical data, not just predicates for material

selection* There are no pre-clinical testing surrogates for clinical data

* What is comfort level for clearance values? Company feels more open clearances allow for

better hydro dynamic fluid film lubrication.

* Do differences in clearances influence dislocation rate, impingement, or subluxation?

* Are there predictive wear tests to show less wear with larger diameter heads?

*

simulator~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~(K

(b) (4)

(b) (4)Ne

Minues repaed y: Mchal Curtney

Branch Chief Concurrence

Z Attach sponsor's handouts or powerpoint presentation

Z Attach list of attendeesJ~ Attach sponsor's minutes, if provided. NOTE: sponsor's minutes have not

necessarily been reviewed for accuracy.

5sT

DePuy - FDA Meeting AgendaASR Modular Head 510(k)

K040627

February 17, 2005ODE HeadquartersRockville, MD

DePuy Attendees:Stephen Peoples, VMD, MS Robert O'Holla

W VP, Clinical and Regulatory Affairs DePuy VP, Regulatory Affairs, Johnson & Johnson

Natalie Heck Marlene Tandy, M.D., J.D.

Manager, Regulatory Affairs, DePuy Senior Counsel, Johnson & Johnson

Rebecca LennardProject Engineer, DePuy

Todd SmithDirector, Research, DePuy

The purpose of the meeting is to discuss and gain clarification regarding several items discussed in

the request for additional information dated January 26, 2005 for K040627.

Hardcopy handouts summarizing the issues to be discussed and clarified relative to the

deficiency letter will be presented at the start of the meeting and used as points of

discussion during the meeting.

General discussion topic:

- ASR XL (submitted as Modular Acetabular System) K040627 - discussion of K040627 device

in comparison to recently 5 10(k) cleared SE predicate devices

Technical discussion topics:

- ASTM F-75 carbon content- Head / cup clearance dimensions-

- HA coating

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Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES


- F l' " From: Reviewer(s) - Name(s) lc&] a L e ran '

Subject: 510(k)Numbe

To: The Record - It is my recommendation that the subject 510(k) Notification:

ElRefused to accept.

'4equires additional information (other than refuse to accept).

ElIs substantially equivalent to marketed devices.

-INOT substantially equivalent to marketed devices.

[-Other (e.g., exempt by regulation, not a device, duplicate, etc.)

Is this device subject to Section 522 Postmarket Surveillance? EYES 2 NO

Is this device subject to the Tracking Regulation? EYES " NO

'El NOWas clinical data necessary to support the review of this 510(k)" ] YES

KZYES [ NOIs this a prescription device'?

E]YES 'U NOWas this 510(k) reviewed by a Third Party? EYES 1I NO

Special 510(k)?

Abbreviated 510(k)? Please fill out form oi H Drive 5lOk/boilers EYES , NO

Truthful and Accurate Statement El Requested $ Enclosed

R'A 510(k) summary OR -A 510(k) statement

f9 The required certification and summary for class III devices

The indication for use form

see algorithm on H drive 510k/Boilers)Combination Product Category (Please

Animal Tissue Source Hl YES El NO Material of Biological Origin 0 YES C NO

The submitter requests under 21 CFR 807.95 (doesn't apply for SBs):

/,4Continued Confidentiality exceeding 90 daysEl No Confidentiality [] Confidentiality for 90 days

Additional Product Code(s) with panel (optional):Predicate Product Code \vith class:

_s? KutJA #71;11]2 Rev iew:

de) (Date)(Branch Chief)

iial (eview:it IirecLor) (Date)(Division Director)

Rc\!sed4;111 I

510(k) "SUBSTANTIAL EQUIVALENCE" DECISION-MAKING PROCESS

New Device Compared toA Markete vc

ow 0ce_ SusatallyNO Do tire Differences Alter the Intended

Descriptive information Does New ce Have Same NOt Y Equlivalent Determination

teme ntt Therapeutid/Diagnosticletc. Effect about New or Marketed Iifdicati

(i eiig a osdr Impact onl Device Requested as Needed

Safiety and Effectiveness)P"ES

New Device Hlas eintended N

Ne0eieleUse and May be "S ntially Equivalent"

New Intended Use

Does New Dcvic eSame

Technological C teistics, NO Could the New New Characteristics- th=.~~Ileeg. Design,Mat

or Effectiveness stosEffectiveess?

NNO Are the Descriptive Characteristics Precise Enough

2 to Ensurc Equivalence 4 ~

[aAcpe il NO [)Mcepteods nr

Arcleprflb miance l.ata

Available to Asses i'quivalciice2 YESAssin of N

thle New Chara risfies?

YES~~~~~~~~~~~~E

NOAre P'erforimance 1D Available

Data Requiredis

Performianice Data Demonstrate l'erlbniiance Data Demonstrate 1

Equivalence? 41 EquivalenceO

NO~~~~~~YE{NO YES

u

In~A ~ ~ ~~~~~Dt~etnnination To Si bstaiinIal E civ alentiA

ew dvice to mrketd de ice I)A requecsts additionalin lbormi ationiiifhe rel atmu~ship bet ,iecuI*ubin§ I0(k)5i s ois copare

ets or reclassi fied post-Aitiedridciits) dev ices is unclearnMarketed and "predicate" (Ire-Anlidicii t

es requtireditri ted testitig informjat ion is someto ...Iihis decisiron isnorh, all~ based on, descriptive ifiloIniation alone, but

01EV 510(k)> the, Center's classification files, or the literature.DaIftztittahe in II,die 5 ) ote


K040627


Division/Branch: DGRND/ORDB

Device Name: DePuy ASRTM Modular Acetabular Cup System

Product To Which Compared (510(K) Number If Known): K965156, K002883, K003523, K021349

YES NO

1. Is Product A Device X If NO Stop

2. Is Device Subject To 510(k)? X IfNO Stop

3. Same Indication Statement? X If YES - Go To 5

4. Do Differences Alter The Effect Or Raise New Issues of If YES = Stop NE Safety Or Effectiveness?


6. Could The New Characteristics Affect Safety Or X If YES - Go To 8 Effectiveness?

7. Descriptive Characteristics Precise Enough? If NO = Go To 10 If YES Stop SE

8. New Types Of Safety Or Effectiveness Questions? X If YES = Stop NE

9. Accepted Scientific Methods Exist? X If NO - Stop NE

10. Performance Data Available? X If NO - Request Data

11. Data Demonstrate Equivalence? Final Decision:

Note: In addition to completing the form on the LAN, "yes" responses to questions 4, 6, 8, and 11, and every "no" response requires an explanation.

K040627

(b) (4)(b) (4) (b) (4)

(b) (4)

1. Intended Use:The DePuy ASR Tm Modular Acetabular Cup System is indicated for use in total hip replacement procedures forpatients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis,osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures.Use of prosthesis is also indicated for patients with congenital hip dysplasia, slipped capital femoral epiphysisand disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

2. Device Description:The acetabular component is designed as a cast CoCrMo alloy (ASTM F-75) one-piece cup with Porocoat®porous coating with the addition of a hydroxyapatite (HA) coating on the outer surface. The acetabular shell hasa highly polished, superfinished internal bearing surface, and is available with outer diameter sizes 44-70 mm in2mm increments with inner diameters ranging from 39-63mm. There is no separate liner component to thissystem, as it is a one-piece acetabular shell used with a unipolar femoral head and a taper sleeve adapter.

The uni femoral head is manufactured from cast high carbon CoCrMo alloy (ASTM F-75) and is available in arange of diameters from 39-63mm in 2mm increments. All of the uni femoral heads have an internal taper which

mates with a CoCrMo taper sleeve adapter specific to the 12/14 or 11/13 tapers corresponding to the externaltapers on DePuy femoral stems. The femoral heads have a highly polished, superfinished exterior bearingsurface, and articulate with corresponding one-piece metal acetabular cups. The sponsor states that the material,outer diameter, clearances and surface finishes of the (currently under IDE

investigation, are identical to the subject unipolar femoral head. .

The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The modularity of

using taper sleeve adapters in two taper options allows for a reduced number of femoral head components whileoffering various femoral head offsets and compatibility with multiple femoral stems. The ASR 12/14 tapersleeve adapters are manufactured from forged cobalt-chrome-molybdenum (CoCrMo) alloy. The 12/14 tapersleeve adapters are offered in neck length options of +1.5, +5, and +8.5. The 11/13 taper sleeve adapters aremanufactured from wrought CoCrMo alloy and were previously cleared in the Ultima Unipolar Head and Sleeve(K965 156) and are offered in neck length options of+0, +6, and +12.

EXPLANATIONS TO "YES" AND "NO" ANSWERS TO QUESTIONS ON PAGE 1 AS NEEDED1. Explain why not a device:2. Explain why not subject to 510(k):3. How does the new indication differ from the predicate device's indication:4. Explain why there is or is not a new effect or safety or effectiveness issue:5. Describe the new technological characteristics:

The subject total metal on metal hip system is composed of a different material, comes in much large sizeswith larger diametrical clearances than the sponsor's own previously cleared predicate device.

6. Explain how new characteristics could or could not affect safety or effectiveness:ay affect the triobiological properties of the system,

which could lead to seizing and loosening. It is unknown what clinical effect these changes will have.

7. Explain how descriptive characteristics are not precise enough:8. Explain new types of safety or effectiveness questions raised or why the questions are not new:

The questions are not new, they are the same safety and effectiveness questions raised for any new metal onmetal hip system.

9. Explain why existing scientific methods can not be used:10. Explain what performance data is needed:

The sponsor should provide clinical data to address the safety concerns raised by the subject changes to theirown predicate device.

11. Explain how the performance data demonstrates that the device is or is not substantially equivalent:

K040627

Q12

(b) (4)

_______

INTERNAL ADMINISTRATIVE FORM:

YES NO X1. DIdh firm request expedited review?

N/A2. Ddwe grant expedited review? 3Have yu verified that the Document is labeled Class III for GMP purposes? X ___

N/A4. Inot, has POS been notified? X5 Is th product a device?

6. Is th device exempt from 5 10(k) by regulation or policy? X x ___7. Is the device subject to review by CDRH?

8. Are you aware that this device has been the subject of a previous NSE decision? x

9. If yes, does this-new 510(k) address the NSE issue(s), (e.g., performance data)? ___ N/A

-10. Are you aware of the submiitter being the subject of an integrity investigation? ___ X N/AII. If, yes, consult the ODE Integrity Officer.

12. Has the ODE Integrity Officer given permission to proceed with the review? (Blue Book N/A

Memo #191-2 and Federal Register 90N0332, September 10, 199 1.

K(040627

(b) (4)


To: K040627.S1From: Elizabeth Frank, Biomedical Engineer, M.S.

FDA/CDRH/ODE/DGRND/Orthopedic Devices Branch (HFZ-4 10)Date: January 24, 2005Device: DePuy ASRTM Modular Acetabular Cup System

Product Code: 87 KWA (21 CFR 888.3330), Class III

Company: DePuy Orthopaedics, Inc.P.O. Box 988700 OrthopaedicsWarsaw, IN 46581-0988

Contact: Natalie Heck, Manager, Regulatory AffairsPhone: 574-372-7469, Fax: 574-371-4939, Email: nheckidpyus.in.com

Recommendation: The file will be placed on hold and the sponsor will be sent an Al letter with the deficiencies

listed at the end of this memo asking for clinical data.

Review:

l. Administrative Requirements:The submission contains a 510(k) Summary, a Truthful and Accuracy Statement and Indications for Usepage.


Acetabular Shell Component:The acetabular component is designed as a cast cobalt-chrome-molybdenum (CoCrMo) alloy (ASTM F-75)one-piece cup with Porocoat® porous coating with the addition of a hydroxyapatite (HA) coating on theouter surface. The acetabular shell has a highly polished, superfinished internal bearing surface, and isavailable with outer diameter sizes 44-70 mm in 2mm increments with inner diameters ranging from 39-63mmn. There is no separate liner component to this system, as it is a one-piece acetabular shell used with aunipolar femoral head and a taper sleeve adapter. The acetabular shell is identical to the

The predicate DePuy Pinnacle system(K003523, K002883) is composed of wrought Co-Cr-Mo alloy (ASTM F-1537) and comes in sizes of 28 or36mm.

The shell component uses the same Porocoat® process used for the predicate device (K002883 &K003523). The coating consists of

Table I includes a summary of the properties of the Porocoat® porouscoating:

Table I: Porocoat® Porous Coating Properties

K040627Pg. I of 17 (>7

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)

(b) (4)The outer surface of the cup has the addition of a hydroxyapatite (HA) coating.

Characteristics of the HA coating on the CoCrMo Porocoat substrate are found in

The HA material conforms to ASTM Fl 185-88 for hydroxyapatite (Ca 5(P04)30H) ceramic.

The sponsor must demonstrate that the HA coating on the porous coated ASR Acetabular Shell does notinfluence wear and device/bone fixation. They will be asked to provide data comparing range-of-motions, shell-liner assembly/disassembly forces, and the acetabular sheltlinsert locking mechanism tothe predicate Pinnacle system (K003523, K002883), which only had a porous coating..

Femoral Component:The uni femoral head is manufactured from cast high carbon cobialt-chromium-molybdenumn (CoCrMo)

alloy (ASTM F-75) and is available in a range of diameters from 39-63mmn in 2mm increments. All of the

uni femoral heads have an internal taper which mates with a CoCrMo taper sleeve adapter specific to the

12/14 or 11/13 tapers corresponding to the external tapers on Deputy femoral stems. The femoral heads

have a highly polished, superfinished exterior bearing surface, and articulate with corresponding one-piece

metal acetabular cups. The sponsor states that the material, outer diameter, clearances and surface finishesof the ) are identical to the subject

unipolar femoral head. The predicate DePuy Pinnacle system (K003523, K002883) is composed of

wrought Co-Cr-Mo alloy (ASTM F-1 537) and comes in sizes of 28 or 36mm.

Diametrical Clearances:The -diametric~al clearances for all femoral implants (femoral heads to acetabular cups) are provided in Table

2 below. The predicate DePuy Pinnacle system has diametrical clearances ranging from .

Table 2: Diametrical Clearances

Taper Sleeve Adapters.The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The modularity




(CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5.The I11/ 13 taper sleeve adapters are manufactured from wrought CoCrMo alloy and were previously cleared

in the LUltima Unipolar Head and Sleeve (K965 156) and are offered in neck length options of +0, +6, and1-12.

K040627Pg. 2 of 17

(b) (4)

(b) (4)(b) (4)

(b) (4)(b) (4)

(b) (4)

A list of all sizes of the DePuy ASRTM Modular Acetabular System is included in Exhibit 1 with a list of

compatible components. Device photographs are included on page 13 and engineering drawings are

provided in Exhibit 2. The taper sleeve adapter drawings are included on page 13 of Supplement 1. Tables

3 and 4 summarize the similarities and differences between the subject and predicate devices.

The ASR Uni Femoral Head and Acetabular Cup System is considered a new metal on metal system thatwill require clinical data. Deficiency #1 discusses the design differences between the subject device and

the predicate DePuy Pinnacle system. The subject device and the , have identical articulating surfaces.

3. Intended Use:The DePuy ASR Modular Acetabular Cup System is indicated for use in total hip replacement procedures


arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of


capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for otherreconstruction techniques.




4. Sterilization:Radiation Type: GammaRadiation Source: Minimum Dosage: Sterility Assurance Level: Sterility Validation Method:

5. Labeling:The instructions for use and draft labels are provided in Exhibit 3. The package labels contain the

appropriate information. The package insert for the DePuy ASR® Modular Acetabular Cup System

contains all appropriate information (device description, indications, contraindications, potential adverse

events, warnings and precautions, cleaning and sterilization information).

K040627Pg. 3 of 17

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6. Testing:

(RDR 151/03):

(RDR 045/03. 143/02. 283/02. 284/02. 043/03. 12/3.ad 3/0)

Testing (RDR 307/02, 044/03. 006/03. 299/02. 037/03. 145/03. 141/03. 082/03 and 065/03):

K040627Pg. 6of 17 1

(b) (4)

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(b) (4) (RDR 117/04):

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K040627Pg. 8 of 17

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7. Sponsor's Information in support of SE:DePuy Pinnacle Metal-on-Metal Acetabular Cup Liner (K003523, K002883)Wright Medical Metal TRANSCEND® Articulation System (K02 1349)DePuy Ultima Unipolar Head and Adapter Sleeves (K965 156)

8. Review of other 51O(k)s/IDEs:Wright Medical Metal TRANSCEND®K Articulation System (K004043/S00lI)Corin USA Cormet Large Diameter Metal on Metal Hip System IDE (G030265)Bionmet M2a TMMagnum Hip System (K(042037)BiometMN2alTM 38mmn(KOlI11 1O)

K040627

Pg. 9 of 17

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(b) (4)

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9. Summary:The sponsor has not demonstrated that their device is SE to the Pinnacle Metal on Metal System. Clinicaldata is necessary for this new metal on metal system. The subject device has identical articulating surfacesto the The sponsor hasbeen asked to complete bench top testing on the subject device, and to provideclinical data in support of the new design of the total metal on metal system. The sponsor will be sent an Alletter with the deficiencies below.

10. Contact History/Requests for More Information:5114/04 - Spoke with Natalie Heck to discuss design and to confirm that this is a new system.

6/3/04 - Sponsor was sent an Al letter requesting more information on this system.7/2/04 - Sponsor requested additional time for response through DMC

7/29/04 - Sponsor requested additional time for response through DMC1 1/30/04 - Natalie Heck left a message, they are getting ready to submit response and have some questions

- They have done more testing on - Asked if there were any particular concerns with instructions for use, none that I recall

12/6/04 - Received document off of hold (90 days up)1/10/05 - Joint team recommends clinical data1/18/05 - Mark Melkerson, DGRND Deputy Director, and Ted Stevens, REDB Chiefrecommend clinical

data at 5 10(k) rounds

E~~ethL~r L )A41Eliz nk MS.(Date)

Orthopedic Devices BranchDivision of General, Restorative and Neurological Devices

Original Deficiencies (with sponsor responses):

I.The proposed DePuy ASR Unit Eemoral Head and Acetabular Cup System is composed of Cast HighCarbon Co-Cr-Mo alloy (ASTM F-75), while your predicate Pinnacle TM Metal-on-Metal Acetabular Cup(K003523 & K002883) is composed of Wrought Co-Cr-Mo alloy (ASTM E-1537). The change in materialalters the articulating surfaces of your system creating new safety concerns.

Report RDR045103

K040627Pg. 10 of 17 13k

(b) (4)

(b) (4)

(b) (4)

(b) (4)

Although the Wright Medical TRANSCEND® Articulation System (K021349) is composed of Cast Co-Cr-Mo alloy (ASTM F-75), this system had its own clearances and tolerances, which were proven to be safeand effective through their own clinical data. Your diametrical clearances and tolerances have not beenidentified in your submission.

pe kix b ip " dtri u *m

The predicate Pinnacle metal on metal system had clearances ranging from 39-63mm. This is a largeincrease in clearance, which has not previously been allowed without supporting clinical data. In

support of the diametrical clearances defined, RDT 117/04,

K040627Pg. 11 of 17

(b) (4)

(b) (4)

(b) (4)

(b) (4)

In addition, you have proposed 39-63mm inner diameters for your acetabular cups with matching femoralhead diameters. Your Pinnacle predicate only exists in 28 and 36 mm sizes and the WrightTRANSCEND® System is 38-54mm. It is unknown what effect increasing the diameter to 62mm will have

on the clinical use of the system. While we have allowed several small increases in diameters withappropriate bench top testing, we are unsure how large is actually safe for clinical use.

The sponsor concludes that there is no increase in safety concerns based upon the larger head diameters of

the subject device. The sponsor has included several abstracts in support of this argument.

All of these design differences can significantly influence the clinical outcomes for metal-on-metal hiparthroplasty devices. These changes present safety concerns that we feel cannot be addressed by preclinical

testing and must be addressed by clinical data to support a determination of substantial equivalence of your510(k). If the clinical data are collected in the US, the clinical data would need to be collected as part of a

FDA-approved investigational device exemption (IDE) application. We recommend that you contact us

prior to submission of an IDE to address any questions related to the clinical study design.

The sponsor has not adequately addressed our concerns regarding the change in material, size anddiametricalclearance. Thesponsorwillbeaskedtoprovideclinicaldata.

2. The test reports submitted in Exhibit 4 refer to a dy). Please clarify which components of this system are identical to the components

in the and which are unique to this submission.

K040627Pg. 12 of 17

/6/0

(b) (4)(b) (4)

(b) (4)

(b) (4)

Please complete approriate wear and corrosion testing on the worst-case scenario for the components in thissubmission or provide an engineering rationale explaining why the current test reports are adequate. Pleasejustify your choice for the worst case femoral head/acetabular cup construct (e.g. most likely the 63mmhead and cup).

3. The submission states, "The modularity of using taper sleeve adapters in two taper options allow for areduced number of femoral head components while offering various femoral head offsets and compatibilitywith multiple femoral stems." The size of the femoral head can affect the fatigue strength of the femoralstem in vivo. Therefore, we

It is not the . Typical stem

K040627Pg. 13 of 17

(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4) (b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

4. The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The taper sleeve

adapter results in a somewhat hollow head design which may be susceptible to additional failure modes (i.e.

fatigue fracture involving the cylindrical shaft in which the Sleeve Adapter fits) that a solid head would not

encounter. We believe to assess the strength of the cylindrical sleeve adapter shaft, is

necessary to establish the safety and effectiveness of the device. Please provide an engineering justification

or a complete test report containing fatigue testing data per ISO 7206-6 with the worst case

head design under worst case physiological loading conditions. Please couple the heads with a stem you

plan to make available for this study. Please justify your choice for the worst case head design (most likelythe 63mm head).

Please see test report RDR063/04 "

.

5. The test reports included in Exhibit 4 address wear concerns, frictional effects have been known to cause component seizing and loosening in metal-on-

metal hip systems. Therefore, we believe the friction between the bearing surfaces is an important

parameter in assessing the safety and effectiveness of a metal-on-metal hip system. Please provide

interfacial, rotational and flexion/extension, frictional torque data on the system both before and after the

devices undergo wear testing.

ReferencesTitle: The Otto Aufranc Award. Wear and lubrication of metal-on-metal hip implants.Author(s): Chan FW, Bobyn JD, Medley JB, Krygier JJ, Tanzer M.Volume: Clin Orthop. 1999 Dec. (369)10-24The implication of polyethylene wear particles as the dominant cause of periprosthetic osteolysis has created a

resurgence of interest in metal-on-metal implants for total hip arthroplasty because of their potential for improved

wear performance. Twenty-two cobalt chromium molybdenum metal-on-metal implants were custom-manufactured

and tested in a hip simulator. Accelerated wear occurred within the first million cycles followed by a marked

K040627Pg. 14 of 17

[c/P

(b) (4)

decrease in wear rate to low steady-state values. The volumetric wear at 3 million cycles was very small, ranging

from 0.15 to 2.56 mm' for all implants tested. Larger head-cup clearance and increased surface roughness were

associated with increased wear. Independent effects on wear of material processing (wrought, cast) and carbon

content were not identified. Implant wear decreased with increasing lambda ratio, a parameter used to relate

lubricant film thickness to surface roughness, suggesting some degree of fluid film lubrication during testing.

This study provided important insight into the design and engineering parameters that affect the wear behavior of

metal-on-metal hip implants and indicated that high quality manufacturing can reproducibly lead to very low wear. As quoted in the text, "Certainly, with similar ranges in clearance and roughness values, no statistical difference

between the high C wrought and high C cast implants was identified.

Title: Analysis of Fluid Film Lubrication in Artificial flip Jiont Replacements with Surfaces of High Elastic Modulus Author(s): Z M din; D Dowson; J Fisher Source: Proceedings of the I MECH E Part H Journal of Engineering in Medicine Volume: 211 Page: 247-256 Abstract: Lubrication mechanisms and contact mechanics have been analyzed for total hip joint replacements made

from hard hearing surfaces such as metal-on-metal and ceramnic-on-ceramic. A similar analysis for ultra-high

molecular weight polyethylene (UHMWPE) against a hard bearing surface has also been carried out and used as a

reference. The most important factor influencing the predicted lubricating film thickness has been found to be the

radial clearance between the ball and the socket. Full fluid film lubrication may be achieved in these hard/hard

bearings provided that the surface finish of the bearing surface and the radial clearance are chosen correctly and maintained. Furthermore, there is a close relation between the predicted contact half width and the predicted

lubricating film thickness. Therefore, it is important to analyze the contact mechanics in artificial hip joint

replacements.

Title: The effect of femoral head diameter upon lubrication and wear of metal-on-metal total hip replacements Author(s): S L Smith; D Dowson; A ASJ Goldsmith Source: Proceedings of the I MECH E Part H Journal of Engineering in Medicine Volume: 215 Page: 161-170 Abstract: It has been found that a remarkable reduction in the wear of metal-on-metal hip joints can be achieved by

simply increasing the diameter of the joint. A tribological evaluation of metal-on-metal joints of 16, 22.225, 28 and

36 nun diameter was conducted in 25 percent bovine serum using a hip joint simulator. The joints were subject to dynamic motion and loading cycles simulating walking for both lubrication and wear studies. For each size of joint

in the lubrication study, an electrical resistivity technique was used to detect the extent of surface separation through a complete walking cycle. Wear of each size of joint was measured gravimetrically in wear tests of at least 2x106

cycles duration. Joints of 16 and 22.225 mm diameter showed no surface separation in the lubrication study. This

suggested that wear would be proportional to the sliding distance and hence joint size in this boundary lubrication

regime. A 28mm diameter joint showed only limi~ted evidence of surface separation suggesting that these joints were

operating in a mixed lubrication regime. A 36 nun diameter joint showed surface separation for considerable pants

of each wvalking cycle and hence evidence of the formation of a protective lubrication film.

3 6Wear testing of 16 and 22.225 nun diameter metal-on-metal joints gave mean wear rates of 4.85 and 6.30 mml/10

cycles respectively. The ratio of these wear rates, 0.77, is approximately the same as the joint diameters ratio,

16/22.225 or 0.72, as expected from simple wear theory for dry or boundary lubrication conditions. No bedding-in was observed with these smaller diameter joints. For the 28 nun diameter joint, from 0 to 2x 106 cycles, the mean

wear rate was 1.62 rm 3̀/l06 cycles as the joints bedded-in. Following bedding in, from 2.0x1 06 to 4.7x10 6 cycles,

the wear rate was 0.54 MM3/106 cycles. As reported previously by Goldsmith et at. in 2000, the mean steady state

wear rate of the 36 mm diameter joints was lower than those of all the other diameters at 0.07 mm3'/106 cycles. For a range of joints of various diameters, subjected to identical test conditions, mean wear rates differed by almost two

orders of magnitude. This study was demonstrated that the application of sound tribological principles to prosthetic

design can reduce the wear of metal-on-metal joints, using currently available materials, to a negligible level.

K040627 Pg. 15 of 17

(b) (4)

(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)

Supplement 1 Deficiencies:

1. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composed of Cast High CarbonCo-Cr-Mo alloy (ASTM F-75), with diametrical clearances of microns and sizes ranging from 39-63mm. Your predicate Pinnacle TM Metal-on-Metal Acetabular Cup (K003523, K002883) is composed ofWrought Co-Cr-Mo alloy (ASTM F-1537), with diametrical clearances between microns and diametersof 28 or 36mm. The material, diametrical clearances and diameters of a total metal on metal hip system

characterize the system, each supported with its own set of clinical data. In Supplement 1, you have attemptedto justify each of these changes with preclinical testing:


b. The diametrical clearances and tolerances provided in Supplement 1 range from with a

c. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System has diameters ranging from 39-

Based on our concerns clinical data are necessary to support a new metal-on- metal system. If the clinical data are collected in the US,the clinical data would need to be collected as part of a FDA-approved investigational device exemption (IDE)application. We recommend that you contact us prior to submission of an IDE to address any questions relatedto the clinical study design.

2. Several of the provided test reports were performed using , and these results arebeing used to support the articulation of the large diameter unipolar femoral heads and ASR acetabular cups in

will affect the loading of the system, as well as wear patterns. We do not believe thatpreclinical testing of a can be appropriately substituted as preclinical testing for a total hipsystem. Therefore the following reports submitted in Supplement 1 are not considered to be applicable to thissubmission and the original deficiencies referencing these reports remain:

K040627Pg. 16 of 17

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)(b) (4)

(b) (4)(b) (4)

(b) (4)(b) (4)

(b) (4)

*In addition, please recognize that the used in this test report is

3. In response to Question 5, you have submitted ue data on the

of this system. As described above, we do not believe preclinical testing of , due to differences in in vivo loading conditions. Therefore,

the original deficiency remains and system is requested. In addition, the provided for the acetabular cup does not address our

concerns regarding .

4. The proposed acetabular component is a cobalt-chrome molybdenum (CoCrMo) alloy one-piece cup with

Porocoat® porous coating with the addition of DuoFix bydroxyapatite (HA) coating on the outer surface. Your

previously cleared Pinnacle metal-on-metal (MOM) acetabular cup is designed as a wrought CoCrMo

superfinished metal liner that assembles into a porous coated, titanium alloy metal shell. We have concerns that

a.

b.

K040627Pg. 17 of 17

(b) (4)

Public Health Service DEPARTME~qT OF HEALTH & HUMAN SERVICES


t_From:i~ Reviewer(s) - Name(s) [1; z,,[,t L Fc

Subject: 510(k) Number qo 6o_ It is my recommendation that the subject 510(k) Notification:

The Record To:

[] Refused to accept.

,14equires additional information (other than refuse to accept).

El is substantially equivalent to marketed devices.

[]NOT substantially equivalent to marketed devices.

O]Other (e.g., exempt by regulation, not a device, duplicate, etc.)

DYES Is this device subject to Section 522 Postmarket Surveillance? *NOI~~~~~~~~~~~'~

DYES ~[ NO

Is this device subject to the Tracking Regulation? IYES El NO10(k)?

Was clinical data necessary to support the review ofthis El NOEYES

Is this a prescription device? f NO, Was this 510(k) reviewed by a Third Party?

UYES

m NOElYES Special 510(k)? BYES 'SNO

Please fill out form on H Drive 510klboilers510(k)?Abbreviated

Truthful and Accurate Statement El Requested'.Enclosed

OR U A 510(k) statement510(k) summaryB~ 5

4 The required certification and summary for class III devices

S~The indication for use form

Combination Product Category (Please see algorithm on H drive 5l0k/Boilers)

E] YES NC Material of Biological Origin0 YES El NO

Animal Tissue Source

The submitter requests under 21 CFR 807.95 (doesn't apply for SEs):

Continued Confidentiality exceeding 90 dt [E Confidentiality for 90 days '$

El No Confidentiality

Additional Product Code(s) with panel (optional): Predicate Product Code with class:

Final Review: (Date) (Division Director)

Revised:4/2/03

510(k) "SUBSTANTIAL EQUIVALENCE" DECISION-MAKING PROCESS

De, c tipcitcdwoc tb,

\ttrkct I )t'Icec ·

"Sbstially Equivalent"

I)cscript.ic Initormaioo.

about New or Marketed Device Requested as Needed

I. c. N c%I

Indication

ice I lave Same

atem entI

ES

NO Do the Difikrences Alterr the Intended

l EffEtTherapeutic/DiagnostiCtc. (in Deciding. MayConsider Impact on

Safety and Etlectiveness)?**

YES

Not StIhstVantiaI

Euivalem Deternination

I1

New Device Has S eIntended NO Device Has

Use and May be SubNew

~~~~~~~New Intended UseQ~~~~~~~~f D)oes New Device Il: Same leclinoloicat hliara ristics. NO Could the New

C 'racttrlstics-. - ~t,~;~--- cgI)esiuin. MIteriji

YES 'Al't Safety or - Raise New Iesot Satety YES

7 Etlketiveness? or Effectiven, Questions?

NONO, Are the Descriptive

Qte

NOCharacteristics Precise Enough

10 to Ensure Equivalence? (NO

Do Acc d ScientificNO Are Pertormance lata

Meth Exist for Available to Asses Equivalence? YES

Assessi Effects of NO th1eNew aracteristics?

C0 SYE'S

Are Perlornia Data Available jI'crlbrmatce

To AssD ataRequired Characteristics? ***

55 (H l Perfornmiance Data Demonstrate

tPertbrniance Data Demonstrate Equivalence?Equivalence? NOiNYESOYES

To )"Stubstantially Equivalent" ToDetematinationITo

jHi(k) Mtbmiissiois compare new devices to marketed devices. FDA requests additional infournation ilt tie relationship betwecn

1arketed and predicate" (pre -Amendmnents or reclassitied post-Anmenldments) devices is uiclear

· * hIlis dcc isis normiallv based on descriptive information alone, but lirmied testing initbrm ation is sometimles required.

·** ~Datamaybe in the 10(k). other 510(k)s, thc Center's classification tilts, or the literaturc.

QS3

SCREENING CHECKLIST

FOR ALL PREMARKET NOTIFICATION [510(k)1 SUBMISSIONS

510(k) Number: 0 406 (V-7

The cover letter clearly identifies the type of 510(k) submission as (Check the

appropriate box):

[I Special 510(k) Do Sections 1 and 2

El Abbreviated 510(k) Do Sections 1,3 and 4

Traditional 510(k) or no identification provided Do Sections 1 and 4

Section 1: Required Elements for All Types of 510(k) submissions:

Present or Missing or Adequate Inadequate

Cover letter, containing the elements listed on page 3-2 of the

Premarket Notification [510)] Manual. Table of Contents. Truthful and Accurate Statement. Device's Trade Name, Device's Classification Name and

Establishment Registration Number. Device Classification Regulation Number and Regulatory Status

(Class 1,Class II, Class III or Unclassified). Proposed Labeling including the material listed on page 3-4 of the

L_Premarket Notification [510)] Manual. Statement of Indications for Use that is on a separate page in the premarket submission. Substantial Equivalence Comparison, including comparisons of the new device with the predicate. 5100c) Sunmary or 510(k) Statement. Description of the device (or modification of the device) including

diagrams, engineering drawings, photographs or service manuals. Identification of legall marketed predicate device. *

Compliance with performance standards. * [See Section 514 of the Act and 21 CFR 807.87 d Class III Certification and Summary. **

Financial Certification or Disclosure Statement for 510(k) notifications with a clinical study. * [See 21 CFR 807.87 (i)]

510(k) Kit Certification *** /A

· - May not be applicable for Special 510(k)s. · * - Required for Class III devices, only.

- See pages 3-12 and 3-13 in the Premarket Notification [510)] Manual and the Convenience Kits Interim Regulatory Guidance.

Section 2: Required Elements for a SPECIAL 510(k) submission:

Present Inadequate or Missing

Name and 510(k) number of the submitter's own, unmodified redicate device.

A description of the modified device and a comparison to the sponsor's predicate device.

b statement thattheritended use(s)and indicationsof the modified device,as described in its labelingare the same as the intended usesand indicationsfor the submitrer's unmodified tredic atedevice.

fundamental scientific technology of the submitter's predicate device. A DesignControl Acivities Summary that the followingincludes

a. ileIdentification of Risk Analysis method(s)used to assess impact ofthe modification on the device and its components, and

Aeiwe'state rmethato asrequirdifby atherisknanalyis allee h t resultsheof the analysis.

Rvieeriscoficmation tand valimdication hacites were plerfred bythedue required verification

b. Based on the Risk Analysis, an identification of and validation activities, including the methods or

tests used and the acceptance criteria to be applied. c. A Declaration of Conformity with design controls that includes the following statemnents:

A statement that, as required by the risk analysis, all verification and validation activities were performed by thc designated individual(s) and the results of the activities demonstrated that the predetermined acceptance criteria were met. Thisstatement is thesigned by individual responsible forthose particular activities. A statement that the manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. This statement is signed by the individual responsible for those particular activities.

Section 3: Required Elements for an ABBREVIATED 510(k)* submission:

Present Inadequate or Missing

For a submission, which relies on a guidance document and/or special control(s), a summary report that describes how the guidance and/or special control(s) was used to address the risks associated with the particular device type. (If a manufacturer elects to use an alternate approach to address a particular risk, sufficient detail should be provided to justify that approach.) For a subimssion, which relies on a recognized standard, a declaration of conformity [For a listing of the required elements of a declaration of conformity, SEE Required Elements for a Declaration of Conformity to a Recognized Standard, which is posted with the 510k)boilers on the H drive.]

For a submission, which relies on a recognized standard without a

declaration of conformity, a statement that the manufacturer intends to conform to a recognized standard and that supporting

data will be available before marketing the device.

For a submission, which relies on a non-recognized standard that has been historically accepted by FDA, a statement that the manufacturer intends to conform to a recognized standard and

that supporting data will be available before marketing the device. For a submission, which relies on a non-recognized standard that

has not been historically accepted by FDA, a statement that the

manufacturer intends to conform to a recognized standard and

that supporting data will be available before marketing the device and any additional information requested by the reviewer in order

to determine substantial equivalence.

Any additional information, which is not covered by the guidance

document, special control, recognized standard and/or non-

recognized standard, in order to determine substantial

equivalence.

- When completing the review of an abbreviated 510(k), please fin out an

Abbreviated Standards Data Form (located on the H drive) and list all the guidance

documents, special controls, recognized standards and/or non-recognized

standards, which were noted by the sponsor.

Section 4: Additional Requirements for ABBREVIATED and TRADITIONAL

510(k) submissions (If Applicable):

Present Inadequate or Missin_

a) Biocompatibility data for all patient-contacting materials, OR

certification of identical material/formulation:

b) Sterilization and expiration dating information:

il sterilizition nrocess ii) validition method of sterilization nrocess

iii) SAT, iv'} nnckaginQ vx snecifly nrogen free vil FTO residues vii) radiation dose viii) Traditional Method or Non-Tradiional Method _

c) Software Documentation: NA/

Items with checks in the 'PresentorAdequate" column do not requiree additional

informationfrom the sponsor. Items with checks in the "Missingor Inadequate"

columninust be submittedbefore substantive review of the document.

Passed Scre ' Yes No

Reviewer:r _ _ _ _ __ _

Concurrence by Review Branch:

Date: /

The deficiencies identified above represent the issues that we believe need to be resolved before our review of your 510(k) submission can be successfully completed. In developing the deficiencies, we carefully considered the statutory criteria as defined in Section 513(i) of the Federal Food, Drug, and Cosmetic Act for determining substantial equivalence of your device. We also considered the burden that may be incurred in your attempt to respond to the deficiencies. We believe that we have considered the least burdensome approach to resolving these issues. If, however, you believe that information is being requested that is not relevant to tie regulatory decision or that there is a less burdensome way to resolve the issues, you should follow the procedures outlined in the "A Suggested Approach to Resolving Least Burdensome Issues" document. It is available on our Center web page at: http://www.fda.gov/cdrh/modact/leastburdensome.htm!

5ee- evY\


K040627


Division/Branch: DGRND/ORDB

Device Name: DePuyASRT odlrActbla u Sse

Product To Which Compared (5 10(K) Number If Known): K965156, K002883. K003523, K021349

YES NO

1. Is Product A Device X if NO =Stop

2. Is Device Subject To 510(k)? X If NO - Stop

Same Indication Statement? X If YES -Go To 53.

4. Do Differences Alter The Effect Or Raise New Issues of If YES - Stop NE Safety Or Effectiveness?


6. Could The New Characteristics Affect Safety Or X If YES = Go To 8 Effectiveness?

=-Go7. Descriptive Characteristics Precise Enough? If NO To 10 If YES - Stop SE

8. New Types Of Safety Or Effectiveness Questions? X If YES = Stop NE

9. Accepted Scientific Methods Exist? X If NO - Stop NE

10. Performance Data Available? X If NO - Request Data

11. Data Demonstrate Equivalence? IFinal Decision:

Note: In addition to completing the form on the LAN, 'yes" responses to questions 4, 6, 8, and 1I, and every "no" response requires an explanation.

K040627

/ InternalAdministrative Form

YES NO1. Did the firm request expedited review? 2. Did we grant expedited review? 3. Have you verified that the Document is labeled Class III for GMP

purposes? 4. If,not, has POS been notified? A// 5. Is the product a device? 6. Is the device exempt from 510(k) by regulation or policy? 7. Is the device subject to review by CDRH? 8. Are you aware that this device has been the subject of a previous NSE

decision? 9. Ifyes, does this new 510(k) address the NSE issue(s), (e.g.,

performance data)? 10.Are you aware of the submitter being the subject of an integrity

investigation? 11. If,yes, consult the ODE Integrity Officer. 12. Has the ODE Integrity Officer given permission to proceed with the /LA

review? (Blue Book Memo #191-2 and Federal Register 90N0332, September 10, 1991.

(b) (4)(b) (4)


To: K040627From: Elizabeth Frank, Biomedical Engineer, M.S.

FDA/CDRI/ODE/DGRND/Orthopedic Devices Branch (HFZ-4 10)

Date: May 24, 2004Device: DePuy ASRTM Modular Acetabular Cup System

Product Code: 87 KWA (21 CFR 888.3330), Class IIICompany: DePuy Orthopaedics, Inc.

P.O. Box 988700 OrthopaedicsWarsaw, IN 46581-0988

Contact: Natalie Heck, Manager, Regulatory AffairsPhone: 574-372-7469, Fax: 574-3714939, Email: nheckdpows.jnj.com

Recommendation: The file will be placed on hold and the sponsor will be sent an Al letter with the deficiencies

listed at the end of the memo asking for clinical data.

Review:

1. Administrative Requirements:The submission contains a 510(k) Summary, a Truthful and Accuracy Statement and Indications for Use

page.


Acetabular Shell Component:The acetabular component is designed as a cobalt-chrome-molybdenum (CoCrMo) alloy one-piece cup with

Porocoat® porous coating with the addition of a hydroxyapatite (HA) coating on the outer surface. The

acetabular shell has a highly polished, superfinished internal bearing surface, and is available with outer

diameter sizes 44-70 mm in 2mm increments. There is no separate liner component to this system, as it is a

one-piece acetabular shell used with a unipolar femoral head and a taper sleeve adapter.

The shell component uses the same Porocoat® process used for the predicate device (K002883 &

K003523). The coating consists of Below is a summary of the properties of the Porocoat® porous coating:

The outer surface of the cup has the addition of a hydroxyapatite (HA) coating.Characteristics of the HA coating on the CoCrMo Porocoat substrate are found in '

The HA material conforms to ASTM F1 185-88 for hydroxyapatite (Ca 5(PO4)3 OH) ceramic.

K040627Pg. 1 of 6

9Go

(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)(b) (4)

Fernoral Component:The uni femoral head is manufactured from cast high carbon cobalt-chromium-molybdenum (CoCrMo)

alloy and is available in a range of diameters from 39-63mm in 2mm increments. All of the uni femoral

heads have an internal taper which mates with a CoCrMo taper sleeve adapter specific to the 12/14 or 11/13

tapers corresponding to the external tapers on DePuy femoral stems. The femoral heads have a highly

polished, superfinished exterior bearing surface, and articulate with corresponding one-piece metal

acetabular cups.

Taper Sleeve Adapters:The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The modularity




(CoCrMo) alloy. The 12/14 taper sleeve adapters are offered in neck length options of +1.5, +5, and +8.5.

The 11/13 taper sleeve adapters are manufactured from wrought CoCrMo alloy and were previously cleared

in the Ultima Unipolar Head and Sleeve (K965156) and are offered in neck length options of +0, +6, and

+12.

A list of all sizes of the DePuy ASRTM Modular Acetabular System are including in Exhibit 1, with a list of

compatible components. Device photographs are included on page 13 and engineering drawings are

provided in Exhibit 2. The following table summarizes the similarities and differences between the subject

and predicate devices.

The subject device is not SE to DePuy's Pinnacle predicate device. The ASR Uni Femoral Head and

Acetabular Cup System is considered a new metal on metal system that will require clinical data. See

deficiency #1. There are a lot of similarities between the subject device and the The design appears to be the

that will fit most femoral stems. The acetabular cup in this submission is the identical design as the

acetabular cup in the . The sponsor must also identify the clearances and

tolerances that will be allowed with the system.

Design/Material:.. ~ ~ ~ ~ ~ ~ D6? s n~ ~~~~iWP db edical : , Dc~uy Ultima?, ~ ~ ~ ~ ~ ~ ~ ~ ~~a unipotitrXdaipfer

acn ; <N + e

F. PrSysR"'tem 9' ifry tm, X9651

Material: ~<K Cast High Carbon Co- Wrought Cast High Carbon: < ~,¢-~ ,,Cr-Mo alloy Co-Cr-Mo alloy Co-Cr-Mo alloy N/A

(ASTM F-75)(ASTM F-1537) (ASTM F-75)Diameters! :5/Q~i K :,~ ; 39-63 mm 28mm & 36 mm 38-54 mm

, ~~~~~~~~~~~~~~~~~~~N/A:________________ '(in 2mm increments) (in 2mm increments)

Articulation ::'R -,uirememtA: Superfimshed surface Superfinished surface Superfinished surface N/A

TaSier eeAdaptes:>TaperOoeometr 11/13 external

12/14 external taper Femoral Heads: taper sleevesleeve adapters Femoral Heads. 12/14 internal taper adaptersmanufactured Cast High Carbon manufacturedfrom wrought 12/14 and 11/13

CoCrMo alloy from wroughtCoCrMo alloy internal tapers

(ASTM F-799) ~~~~(ASTM F-75) CoCrMo alloy(ASTM F-1537)

Taper/Neck Taper Sleeve Adapters: 28mm Femoral Heads: Femoral Heads: Taper Sleeve

K040627Pg. 2 of 6

(b) (4)

(b) (4)

12/14 taper: 12/14 taper: 12/14 taper: Adapters::RO +l.5, +5, +8.5 +1.5, +5, +8.5 -3.5, 0, +3.5 11/13 taper:

11/13 taper: +0, +6, +12i??-~~ ~ ~~~ 11 3 apr +0, +3, +6

~ ~ ~~+0, +6, +12 36mmn Femoral Heads:(se Ultima taper 12/14 taper: -2, +1.5,

sleeve adapters) +5, +8.5, +1211/13 taper: +0, +3,

Comonn: nee h+6, e+9 +12

Mated Cast High Carbon Wrought Cast High CarbonCo-Cr-Mo alloy CoCrMo alloy Co-Cr-Mo alloyN/A

~:~ (ASTM F-75 ) (ASTM F-1537) (ASTM F-75)

oD:~p'at'mg:, i&f, PorocoatV Porousji Coating with DuoFix T N/A Porous coated N/A

HA coating

Outer Diameter: 44-70mm 48-66mm 46-64mm N/> i ~:%, "g ~~~~~~~~~~~~~~N/A

.Sm 2mm increments) (in 2mm increments) (in 2mm increments)

Inner Diaifietert?>: 39-63mm 28 & 36mm 36-54mm N/A

Superumisbed Surface Superfinished Surface Superfinished Surface N/ARe uirements ; uefihd ufc

3. Intended Use:The DePuy ASRTM Modular Acetabular Cup System is indicated for use in total hip replacement procedures


arthritis, osteoarthritis, post-traumatic arthritis, .collagen disorders, avascular necrosis, and nonunion of


capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other

reconstruction techniques.




4. Sterilization:Radiation Type: GammaRadiation Source: Minimum Dosage: Sterility Assurance Level: Sterility Validation Method: -

Pyrogen-Free: No claims will be made

5. Labeling:The instructions for use and draft labels are provided in Exhibit 3.

6. Testing:

K040627Pg. 3 of 6

(b) (4)(b) (4)

(b) (4) (b) (4)

(b) (4)

(b) (4)

(b) (4)

7. Sponsor's Information in support of SE:DePuy Pinnacle Metal-on-Metal Acetabular Cup Liner (K003523, K002883)

Wright Medical Metal TRANSCEND® Articulation System (K021349)

DePuy Ultima Unipolar Head and Adapter Sleeves (K965156)

8. Review of other 510(k)s/IDEs:Wright Medical Metal TRANSCEND® Articulation System (K004043/S001)

Corin USA Cormet Large Diameter Metal on Metal Hip System IDE (G030265)

9. Summary:The sponsor has not proven their device is SE to the Pinnacle Metal on Metal System. Clinical data is

necessary for this new metal on metal system. The new device is very similar to the

The sponsor has been asked to clarify the differences

between the two systems and complete appropriate bench top testing. The sponsor will be sent an Al letter

with the deficiencies below.

10. Contact History/Requests for More Information:5/14 - Spoke with Natalie Heck to discuss design and to confirm that this is a new system.

AthLF~~~~~~, L tztoEliz~t~et L. Frank, M.S. (Date)Orthopedic Devices BranchDivision of General, Restorative and Neurological Devices

K040627Pg. 4 of 6

(b) (4)

(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

Deficiencies:

l. The proposed DePuy ASR Unit Femoral Head and Acetabular Cup System is composed of Cast High Carbon

Co-Cr-Mo alloy (ASTM F-75), while your predicate PinnacleTM Metal-on-Metal Acetabular Cup (K003523

& K002883) is composed of Wrought Co-Cr-Mo alloy (ASTM F-1537). The change in material alters the

articulating surfaces of your system creating new safety concerns. Although the Wright Medical

TRANSCEND® Articulation System (K021349) is composed of Cast Co-Cr-Mo alloy (ASTM F-75), this

system had its own clearances and tolerances, which were proven to be safe and effective through their own

clinical data. Your diametrical clearances and tolerances have not been identified in your submission.

In addition, you have proposed 39-63mm inner diameters for your acetabular cups with matching femoral

head diameters. Your Pinnacle predicate only exists in 28 and 36 mm sizes and the Wright TRANSCEND®

System is 38-54mm. It is unknown what effect increasing the diameter to 62mm will have on the clinical use

of the system. While we have allowed several small increases in diameters with appropriate bench top

testing, we are unsure how large is actually safe for clinical use.

All of these design differences can significantly influence the clinical outcomes for metal-on-metal hip

arthroplasty devices. These changes present safety concerns that we feel cannot be addressed by preclinical

testing and must be addressed by clinical data to support a determination of substantial equivalence of your

5 10(k). If the clinical data are collected in the US, the clinical data would need to be collected as part of a

FDA-approved investigational device exemption (IDE) application. We recommend that you contact us prior

to submission of an IDE to address any questions related to the clinical study design.

2. The test reports submitted in Exhibit 4 refer to a

Please clarify which components of this system are identical to the components in the

and which are unique to this submission. Please complete approriate

on the worst-case scenario for the components in this submission or provide an engineering

3. The submission states, "The modularity of using taper sleeve adapters in two taper options allow for a

reduced number of femoral head components while offering various femoral head offsets and compatibility

with multiple femoral stems." The size of the femoral head can affect the fatigue strength of the femoral stem

in vivo. Therefore, we believe fatigue testing to assess the strength of the worst case femoral stem, coupled

with the worst case femoral head, is necessary to establish the safety and effectiveness of the system. Please

provide an engineering justification or complete fatigue testing on your five worst case head/stem constructs.

Please justify your choice for the worst case head/stem construct (e.g., head with largest lateral offset, stem

most likely to fail in fatigue).

4. The subject heads use taper sleeve adapters to mate the femoral head to the femoral stem. The taper sleeve

adapter results in a somewhat hollow head design which may be susceptible to additional failure modes (i.e.

fatigue fracture involving the cylindrical shaft in which the Sleeve Adapter fits) that a solid head would not

encounter. We believe , to assess the strength of the cylindrical sleeve adapter shaft, is

5. The test reports included in Exhibit 4 address fretting, In addition to

have been known to cause component seizing and loosening in metal-on-

metal hip systems. Therefore, we believe the friction between the bearing surfaces is an important parameter

in assessing the safety and effectiveness of a metal-on-metal hip system. Please provide

K040627Pg. 5 of 6

(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)

testing.

K040627Pg. 6 of 6

510(k),SUBSTANTIAL EQUIVALENCE" iECISION-MAKING PROCESS

0~~~~ Not Substntial lv

NO )o (tie DilIuzreas Alter (ticeInteded¾sNe I )e 1ijtCIt itin ehive Sane

YES Ejquivaleti Deternination uent'? I- TherapcutieDiagnostic/etc. Elllzet

about New or Marketed Indicatioi 5 (in Deciding. May Consider Impact on

asd NeededD evicR e equeste DeviceRW.ested as Needed Safety and Effectivencss)Y?*

NONew Device HIas Sa Intended

Use and May be '-Subs Equivalen N vyice as 0

New Intended Use

w Device I~ yeSa5Noes lo V~eSameNe

oNO Could the ew Dothe New Characteristics'Icelinlo t Char edristics.

<etc? - Characteristicse DIesin. Materi YES CAflect Safety or ), RaiseNewTypesofSafety

or Effectiveness Questions?Effecti eless?

NNONO Are itheDcriptve

NO-- tic~ recise Enough ivalence?

( Do Accepted Scientific NO A reNO

Ar~founmanee Data Availabl Ases Dia Methods Exist for

Assessing Eftects of NO

the New Characteristics?

(D i '~~~~~jYSYES

Are perfonlance Data Available NO To Assess Effects of New

PerfoataRee Characteristics? *** Data Required

Data DemonstrateDperformancePerfbri nc Data Equivalence? 4

-,,forw Data ions-rate

'. YES NO

T.uiat W

ubistantial eemnatToIo A

requests additioaal inobrmation it the relalionship betweei pare ter devices to marketed devices -DA

Si 0(1(k) Stbc ci ssiru otin* 5

ecits or reclassitied post-Auitcidiilents) devices is unclear. iulalrkcetnd I "piedicate (,ic,-A ...cidii~

n le fl l io

I atotie. but limited testing itltorulation is 5o0usdi s required i .. r...l.llly based on descriptive in ruua

·* T itis dccisioni

th¢Center's elassiticatioil files. or (lie liherature. Data ittlahe iin the 510(k). other 5;10(k s

*'*


Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation


December 03, 2004 Rockville, Maryland 20850

DEPUY ORTHOPAEDICS, INC. 510(k) Number: K040627 700 ORTHOPAEDIC DR. Product: DEPUY ASR P.O. BOX 988 MODULAR

WARSAW, IN 46581 ACETABULAR CUP ATTN: NATALIE HECK SYSTEM

The additional information you have submitted has been received.

We will notify you when the processing of this submission has been

completed or if any additional information is required. Please

remember that all correspondence concerning your submission MUST be sent to the Document Mail Center (HFZ-401) at the above

letterhead address. Correspondence sent to any address other than the one above will not be considered as part of your official

premarket notification submission. Also, please note the new Blue Book Memorandum regarding Fax and E-mail Policy entitled, "Fax and E-Mail Communication with Industry about Premarket Files

Under Review. Please refer to this guidance for information on current

fax and e-mail practices at www.fda.gov/cdrh/ode/a02-Ol.html.

The Safe Medical Devices Act of 1990, signed on November 28, states that you may not place this device into commercial distribution until you receive a letter from FDA allowing you to do so. As in the past, we intend to complete our review as quickly as possible.

Generally we do so 90 days. However, the complexity of a submission or a requirement for additional information may occasionally cause the review to extend beyond 90 days. Thus, if you have not received a written decision or been contacted within 90 days of our receipt

date you may want to check with FDA to determine the status of your submission.

If you have procedural or policy questions, please contact the Division of Small Manufacturers International and Consumer Assistance

(DSMICA) at (301) 443-6597 or at their toll-free number (800) 638-2041, or contact me at (301) 594-1190.

Sincerely yours,


It4

*Deduy K o

Traditional

510(k) Submission

K040627/5


Request for Additional Information Dec 2, 2004

DRIVE WARSAW IN 46581.008700 ORTHOPAEDIC

*DeRiy 510(k): Preinarket Notification

DePuy Orthopaedics, Inc. P o 8December 2, 2004 700 Orthopaedic Drive Warsaw, Indiana 46581 -0988Food and Drug Administration USACDRI-IODE Tel: +1(574) 267 8143Document Mail Center (HFZ-401)

9200 Corporate Blvd. Rockville, MD 20850

Attn: Ms. Elizabeth Frank

Re: Additional Information- K040627 DePuy ASR Tm Modular Acetabular Cup Systemn

Dear Ms. Frank:


DePuy ASR~ Modular Acetabular Cup System, K(040627, currently under review by FDA. This

submission is made to comply with the request for additional information made by written request

dated June 03, 2004. Please find the questions and corresponding responses in the attached addendum.

Pursuant to 21 CFR 807.95(c) (3), DePuy considers our intent to market this device and this 5 10(k) DePuysubmission to be confidential commercial information and requests that FDA treats it as such.

has taken precautions to protect the confidentiality of the intent to market these devices. We

understand that the submission to the government of false information is prohibited by 18 U.S.C. 1001

and 21 U.S.C. 331(q).

into domestic commercialDePuy Orthopaedics acknowledges that the introduction of this device by the Food and Drugdistribution will be contingent upon written clearance of the 510(k)

Administration.

Thank you in advance for your consideration of our application. If there are any further questions -

regarding this submission, please feel free to contact me via phone (574) 372-7469, fax (574) 371

4987, or email at nheckratdtwus n'cm

Regards,

NatleHc Manager, Regulatory Affairs.j

IDePuy Orthopaedics, Inc.

_j ~ /j

(b) (4)

Addendum to DePuy ASR TM Modular Acetabular Cup System 510(K), K040627Written request for Additional information, June 03, 2004; extension requested for December 03,

2004:…---- ------ --------- - ------- ---- -------- ------…------------… ---------- …-

Question la: The change in material alters the articulating surfaces of your system creating

safety concerns (ASR- Cast CoCr; Pinnacle- Wrought CoCr)

Response la:

We conclude from the testing performed that there is no increase in safety concerns based upon the

change from wrought CoCr to cast CoCr for the ASR lUni head and cup bearing couple.

As further support for the material choice of the subject device, we have included summaries of the

following journal articles:

Title: The Otto Aufrauc Award. Wear and lubrication of metal-on-metal hip implants.

Author(s): Chan FW, Robyn JD, Medley JB, Krygier JJ, Tanzer M.Source: PMID: 10611857 [PubMed - indexed for MEDLINE]Volume: Clini Orthop.l999 Dec. (369)10-24Department of Biomedical Engineering, McGill University, Montreal, Quebec, Canada.

The implication of polyethylene wear particles as the dominant cause of periprosthetic osteolysis has

created a resurgence of interest in metal-on-metal implants for total hip arthroplasty because of their

potential for improved wear performance. Twenty-two cobalt chromium molybdenum metal-on-metalimplants were custom-manufactured and tested in a hip simulator. Accelerated wear occuared within

the first million cycles followed by a marked decrease in wear rate to low steady-state values. The

volumetric wear at 3 million cycles was very small, ranging from 0. 15 to 2.56 mm 3 for all implants

tested. Larger head-cup clearance and increased surface roughness were associated with increased

wear. Independent effects on wear of material processing (wrought, cast) and carbon content were not

identified. Implant wear decreased with increasing lambda ratio, a parameter used to relate lubricant

film thickness to surface roughness, suggesting some degree of fluid film lubrication during testing.

This study provided important insight into the design and engineering parameters that affect the wear

behavior of metal-on-metal hip implants and indicated that high quality manufacturing can

reproducibly lead to very low wear. As quoted in the text, "Certainly, with similar ranges in clearance

IL

(b) (4)

and roughness values, no statistical difference between the high C wrought and high C cast implants

was identified."

Title: Engineering issues and wear performance of metal on metal hip implants.

Author(s): Chan FW, Robyn JD, Medley JB, Krygier JJ, Yine S, Tanzer M.

Source: PMID: 8981885 [PubMed - indexed for MEDLINE]Volume: Clin Orthop. 1999 Dec.; (333) 96-107

Jo Miller Orthopaedic Research Laboratory, Montreal General Hospital and McGill University,

Quebec, Canada.

A major concern in total hip arthroplasty is the generation of polyethylene wear particles at the

articulating surfaces and resulting macrophage mediated periimplant osteolysis. There is renewed

interest in metal on metal bearings as a solution to this problem in view of their potential for greatly

improved wear performance. Using a commercially available hip simulator, the wear performance of

metal on metal femoral head and acetabular cup combinations was evaluated and various parameters

affecting metal on metal implant wear were identified. Nine implants custom manufactured from 2

medical grades of CoCrMo alloy (ASTM F1537-95 and F75-92) were tested within bovine serum as

the lubricant to 3 million cycles (equivalent to approximately 3 years of service in vivo). The

progressive wear of the components was determined by gravimetric methods at approximately every

300,000 cycles. The wear rates were characterized by an initial period of accelerated wear after which

a lower steady state wear rate was observed for subsequent cycles. The presence of calcium phosphate

films on the component surfaces, the microstructure of the lower carbon wrought alloy, and increased

effective radii (decreased diametrical clearances) were identified as factors that may be favorable to

improved wear performance. The extent of the effect on wear of each parameter, however, cannot be

discerned at this point and necessitates a study in which parametric changes are more tightly

controlled. The present study suggests that the use of metal on metal articulating surfaces may mitigate

the problem of osteolysis by offering improved wear performance.

Question 1k Your diametrical clearances and tolerances have not been identified in your

submission.

Responselib: The diametrical clearances for all femoral implants (femoral heads to acetabular cups)

are given in the table below.

Femoral mln Size Diametrical Clearance (mm) (b) (4)

3s-

(b) (4)

(b) (4)

Representative Product Layout

DERUH ASPTM MODULAR PRODDUOT LAYCLI

4

Note: In addition to the requested information, DePuy would like to make a correction to the part

number listing for the Uni Femoral Head Size 47mm, and the description to the taper sleeve adapters in the components table.

DePuy ASRTM Modular Acetabular System

Description Sizing

Uni Femoral Head Size 39mm 38.50D

Uni Femoral Head Size 41mm 40.5 0D

Uni Femoral Head Size 43mm 42.500

Uni Femoral Head Size 45mm 44.5 OD



Uni Femoral Head Size 49mm 48.5 0D

Uni Femoral Head Size 51mm 50.50D

Uni Femoral Head Size 53mm 52.500



Uni Femoral Head Size 59mm 58.46OD

Uni Femoral Head Size 61mm 60.44OD


Acetabular Shell size 44mm 44 OD x 38.6 ID




Acetabular Shell size 52mm 52 OD x 45.60 [D




Acetabular Shell size 60mm 60 OD x 52.60 1D

Acetabular Shell size 62mm 62 OD x 54.60 1D

Acetabular Shell size 64amm 64 OD x 56.60 1D




Taper Sleeve Adapters 12/14 +2 +2mm neck Ing, 12/14 taper



Catalog Part Number Number

999800139 999890239 999800141 999890241

999800143 999890243

999800145 999890245

999800146 999890246

999800147 999890247 999800149 999890249

999800151 999890251

999800153 999890253

999800155 999890255

999800157 999890257

999800159 999890259 999800161 999890261

999800163 999890263

999803944 999800744

999804146 999800746

999804348 999800748

999804550 999800750

999804652 999800752 999804754 999800754

999804956 999800756

999805158 999800758 999805360 999800760

999805562 999800762

999805764 999800764 999805966 999800766

999806168 999800768

999806370 999800770

999800102 999800312 999800105 999800315

999800108 999800318

An updated sleeve adapter drawing is included as an exhibit to this response.

%5 5

(b) (4)

Question lc: It is unknown what effect increasing the diameter to 63mm will have on the

clinical use of the system (ASR- 39 to 63mm; Wright 38 to 54mm)

Response lc: The expected performance of the larger diameter heads/cups is supported by thefollowing:

-

-

We conclude from the analyses performed that there is no increase in safety concerns based upon the

larger head diameters of the subject device as compared to the predicate device.

As further support for the range of head diameters of the subject device, we have included abstracts of

the following articles:

Title: Analysis of Fluid Film Lubrication in Artificial Hip Joint Replacements with Surfaces of

High Elastic ModulusAuthor(s): Z M Jinl; D Dowson ; J Fisher2

Source: Proceedings of the I MECH E Part H Journal of Engineering in Medicine

Volume: 211 Page: 247- 256DOI: 10.1243/0954411971534359Publisher: Professional Engineering Publishing

Abstract: Lubrication mechanisms and contact mechanics have been analysed for total hip joint

replacements made from hard bearing surfaces such as metal-on-metal and ceramic-on-ceramic. A

similar analysis for ultra-high molecular weight polyethylene (UHMWPE) against a hard bearing

surface has also been carried out and used as a reference. The most important factor influencingthe predicted lubricating film thickness has been found to be the radial clearance between the ball

and the socket. Full fluid film lubrication may be achieved in these hard/hard bearings providedthat the surface finish of the bearing surface and the radial clearance are chosen correctly and

maintained. Furthermore, there is a close relation between the predicted contact half width and the

predicted lubricating film thickness. Therefore, it is important to analyse the contact mechanics in

artificial hip joint replacements. Practical considerations of manufacturing these bearing surfaceshave also been discussed.© The Institution of Mechanical Engineers 2004

Title: The effect of femoral head diameter upon lubrication and wear of metal-on-metal total hipreplacementsAuthor(s): S L Smith'; D Dowson2; A A J Goldsmith3

Source: Proceedings of the I MECH E Part H Journal of Engineering in MedicineVolume: 215 Page: 161 - 170DOI: 10.1243/0954411011533724

Publisher: Professional Engineering Publishing

Abstract: It has been found that a remarkable reduction in the wear of metal-on-metal hip joints

can be achieved by simply increasing the diameter of the joint. A tribological evaluation of metal-

on-metal joints of 16, 22.225, 28 and 36 mm diameter was conducted in 25 per cent bovine serum

using a hip joint simulator. Thejoints were subject to dynamic motion and loading cyclessimulating walking for both lubrication and wear studies. For each size ofjoint in the lubrication

study, an electrical resistivity technique was used to detect the extent of surface separation through

a complete walking cycle. Wear of each size ofjoint was measured gravimetrically in wear tests of

at least 2x 106 cycles duration. Joints of 16 and 22.225 mm diameter showed no surface separation

in the lubrication study. This suggested that wear would be proportional to the sliding distance andhence joint size in this boundary lubrication regime. A 28 mm diameterjoint showed only limited

evidence of surface separation suggesting that these joints were operating in a mixed lubrication

regime. A 36 mm diameterjoint showed surface separation for considerable parts of each walking

cycle and hence evidence of the formation of a protective lubricating film.Wear testing of 16 and 22.225 mm diameter metal-on-metal joints gave mean wear rates of 4.85

and 6.30 mm3/106 cycles respectively. The ratio of these wear rates, 0.77, is approximately the

same as the joint diameters ratio, 16/22.225 or 0.72, as expected from simple wear theory for dry

or boundary lubrication conditions. No bedding-in was observed with these smaller diameter

joints. For the 28 mm diameter joint, from 0 to 2x 106 cycles, the mean wear rate was 1.62mm 3/106 cycles as thejoints bedded-in. Following bedding-in, from 2.0x 10 to 4.7x 106 cycles, the

wear rate was 0.54 mm 3/106 cycles. As reported previously by Goldsmith et al. in 2000, the mean

steady state wear rate of the 36 mm diameterjoints was lower than those of all the other diameters

at 0.07 mrm3/106 cycles. For a range ofjoints of various diameters, subjected to identical test

conditions, mean wear rates differed by almost two orders of magnitude. This study hasdemonstrated that the application of sound tribological principles to prosthetic design can reduce

the wear of metal-on-metal joints, using currently available materials, to a negligible level.© The Institution of Mechanical Engineers 2004

Question 2a: Clarify which components of this system are identical to the components in theresurfacing IDE study and which are unique to this submission

Response 2a:

Component 510(k) IDE

7

(b) (4)

(b) (4)

Question 2b: Complete appropriate wear and corrosion testing on the worst-case scenario forthe components in this submission or provide an engineering rationale explaining why thecurrent test reports are adequate. Justify your choice for the worst case femoralhead/acetabular cup construct.

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)(b) (4)

Question 3: The size of the femoral head can affect the fatigue strength of the femoral stem in vivo.Provide worst case femnoral stem, coupled with the worstcase femoral head or an engineering justification explaining why the current test reports areadequate.

Response 3:- It is not the size of the femoral head that affects the fatigue strength of the femoral stem but rather

the femoral head offset. Typical stem is performed with the worst-case offset,32mm +17, because this creates the longest moment arm.

Question 4: The taper sleeve adapter results in a somewhat hollow design, which may besusceptible to additional failure modes that a solid head would not encounter. Provide anengineering justification or a complete test report containing

heads with the worst case head design under the worst case .

Response 4: Please find attached test report RDR063/04 "

d.

Question 5: Provide e data on thesystem both before and after the devices undergo .

5

(b) (4)

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Exemption 4: Internal Test Report

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Public Health Service DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Center for Devices and

RadiologiCal Health


Document Mail Center (HFZ-40l)


Rockville, MarylandMay 24, 2005

510(k) Number: K040627DEPUlY ORTHOPAEDICS, INC. Product: DEPUY ASR700 ORTHOPAEDIC DR.

MODULARP.O. BOX 988 ACETABULAR CUP WARSAW, IN 46581 SYSTEMATTN: NATALIE HECK

The additional information you have submitted has been received.

We will notify you when the processing of this submission has been

if any additional information is required. Pleasecompleted or remember that all correspondence concerning your submission MUST

the Document Mail Center (HFZ-401) at the abovebe sent to to any address other thanletterhead address. Correspondence sent

part of your officialabove will not be considered asthe one Also, please note the new

premarket notification submission.

Blue Book Memorandum regarding Fax and E-mail Policy entitled,

"Fax and E-Mail Communication with Industry about Premarket Files

this guidance for information on current Under Review. Please refer to

fax and e-mail practices at www.fda.gov/cdrh/ode/aO2-Ol.html.

signed on November 28, statesThe Safe Medical Devices Act of 1990,

that you may not place this device into cormmercial distribution

until you receive a letter from FDA allowing you to do so. As in quickly as possible.

the past, we intend to complete our review as

so 90 days. However, the complexity of a submissionGenerally we do

for additional information may occasionally cause or a requirement extend beyond 90 days. Thus, if you have not receivedthe review to

our receipta written decision or been contacted within 90 days of

check with FDA to determine the status of yourdate you may want to submission.



at their toll-free number (800) 638-2041,(DSMICA) at (301) 443-6597 or

contact me at (301) 594-1190.or

Sincerely yours,


Premarket Notification Section Office of Device Evaluation

Center for Devices and

Radiological Health

1-3

/'~ 9k-0 7/6

*De~uy

Traditional

510(k) Submission

K040627

DePuy ASR Th Modular Acetabular Cup System

Request for Additional Information May 23, 2005

DRIVE IN 46581-gWW700 ORTHOPAEDIC WARSAW

*De~uy a o~t~ntt

4 4Olcompany


700 Orthopaedic Drive PO Box 988 Warsaw, Indiana 46581-0988 USA Tel: +1(219) 267 8143

510(k): Premarket Notification Tel: +1(219) 267 8143

May 23, 2005

Food and Drug Administration CDRHIODE Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, MD 20850

Ann: Ms. Elizabeth Frank

M Modular Acetabular Cup SystemRe: Additional Information - K040627 DePuy ASR T

Dear Ms. Frank:


DePuy ASR T ThisM Modular Acetabular Cup System, K040627, currently under review by FDA.

submission is made to comply with the request for additional information made by letter request

on January 26, 2005.

our intent to market this device and thisPursuant to 21 CFR 807.95(c) (3), DePuy considers

510(k) submission to be confidential commercial information and requests that FDA treats it as

such. DePuy has taken precautions to protect the confidentiality of the intent to market these

We understand that the submission to the government of false information is prohibiteddevices-by 18 U.S.C. 1001 and 21 U.S.C. 331(q).

DePuy Orthopaedics acknowledges that the introduction of this device into domestic commercial

distribution will be contingent upon written clearance of the 510(k) by the Food and Drug

Administration.

Thank you in advance for your consideration of our application. If there are any further questions

regarding this submission, please feel free to contact me via phone (574) 372-7469, fax (574)

3714987, or email at nheckqdpovs.ini.com.

Regards,

Manager, Regulatory Affairs DePuy Orthopaedics, Inc.

A Rationale and Technical Overview is provided to identify the history and design

rationale specific to the DePuy ASRTM Modular Acetabular Cup System, and metal-on-

metal acetabular bearing couples in general.

Rationale and Technical OverviewOf the ASR Modular Acetabular Cup System

It1

(b) (4)

Tribology and Design Parameters of MOM Wear Couples

2

(b) (4)

3

(b) (4)

4

(b) (4)

5

(b) (4)

(b) (4)

I

6

7

(b) (4)

(b) (4)

(b) (4)

(b) (4)

Addendum to DePuy ASR T M Modular Acetabular Cup System 510(K), K040627

Letter Request for Additional Information, January 26, 2005:

Question 1:

Response la:ASTM F-75 requires that the carbon content of the cobalt chromium molybdenum

(CoCrMo) casting alloy material be within the range of 0% - 0.35%. The internal raw

material specification for the subject ASRTM uni femoral head and cup specifies a carbon

content within the range of A copy of the internal raw material

specification IRM 103-21-001 is provided in the rationale and technical overview.

Adherence to this internal specification guarantees the device will have a carbon content

within the of the range required by the ASTM specification.

Based on the carbon content requirements and testing performed, we conclude that there

is no increase in safety concerns based upon the change from wrought CoCrMo to cast

CoCrMo for the ASR uni head and cup bearing couple.

9

(b) (4)

(b) (4)

(b) (4)h. The diametrical clearances and tolerances provided in Supplement I rane from

Response lb:Please note the stated predicate Pinnacle Metal-on-Metal Acetabular Cup System

clearance range in the deficiency letter require correction. The minimum and maximum

clearances (microns) for the approved metal-on-metal systems and the ASR modular

system are summarized in the table below.

The ASR Modular Acetabular Cup System design has clearances within the range of

those for previously cleared metal-on-metal devices. Furthermore, the overall range of

clearances for the ASR Modular device is equal to that of the Wright Medical

TRANSCEND device (1 10 microns).

10

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

Based on the bearing design and performed, we conclude that there is no

increase in safety concerns based upon the increase in diametrical clearance.

has

Based on our concerns regarding the changes in

, we believe clinical data are necessary to support a new metal-on-

metal system. If the clinical data-are collected, in the US, the clinical data would

need to be collected as part of a FDA-approvcd investigational device exemption

(IDE) application. We recommend that you contact us prior to submission of an


Response lc:As explained in the rationale and technical overview, increasing the bearing diameter

enhances the wear performance of a metal-on-metal articulation because

elastohydrodynamic lubrication is more easily achieved. Therefore, the larger ASR

bearing diameters represent a better wear scenario than the predicate 36mm Pinnacle

Metal-on-Metal Acetabular Cup System. Additionally, larger diameter heads offer greater

resistance to subluxation and dislocation as well as improved range of motion.

RDR 117/04

2:1

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

We conclude from the analyses performed that there is no increase in safety concerns

based upon the larger head diameters of the subject device as compared to the predicate

device.

2. Several of the provided test reports were performed using devices,

and these results are being used to support the articulation of the large diameter

unipolar femnoral heads and ASR acetabular cups in the subject submission. In

hile

assembly. Differences between the will affect the loading of the system, as well as wear patterns, We do not believe

that preclinical testing of a can be appropriately substituted as

preclinical testing for a total hip system. Therefore the following reports submitted in

Supplement I are not considered to be applicable to this submission and the original

deficiencies referencing these reports remain:

Response 2:By the nature of their design, hip joint replacement devices transmit load through the

bearing surface, specifically the joint contact area. This is no different whether the

femoral component takes the form of a modular head and femoral stem or a surface

replacement device. In

12

(b) (4)

(b) (4)

(b) (4)

(b) (4)applicable to the subject device because the two systems utilize the identical acetabular

cup and the femoral component for the is identical in bearingdesign (material, outer diameter, surface finish and bearing clearance) to the subject large

diameter unipolar femoral heads.

We believe that the following test reports are applicable based on the stated reasons.

13

(b) (4)

(b) (4)

(b) (4)(b) (4)

3. In response to Question 5, you have submitted data on the resurfacing components of this system. As described above, we do

not believe preclinical testing providecomparable results, due to differences in in vivo loading conditions. Therefore, theoriginal deficiency remains and both

is requested. In addition, the provided testing forthe acetabular cup does not address our concerns regarding

.

Response 3:In response to testing the m, please see theresponse to Question 2 above.

14

(b) (4)

(b) (4)(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

(b) (4)

15

(b) (4)

(b) (4)

4. a)Data companng ranges of motion, shell-liner assemblyfdisassembly forces,acetabular shell/inscrt locitng mechanism and design to that of the metal/metalpredicate Pinnacle system (K003523, K002883).

Response 4 a)

Ranges of Motion:

Pinnacle Metal-on-Metal ASR Modular

Bearing Smallest Shell ROM Bearing Smallest Shell ROMID OD ID OD

The DePuy ASR T M Modular Acetabular Cup System is comprised of a one-piece metalacetabular cup, a unipolar femoral head, and a taper sleeve adapter.

The acetabular cup consists of a cobalt-chromium molybdenum (CoCrMo) alloy one-piece cup with Porocoat® porous coating. The outer porous coated surface of the cuphas the addition of a hydroxyapatite (HA) coating. There are no separate linercomponents to this system, as the liners are integral to the one-piece acetabular cups.

The uni femoral head is manufactured from cobalt-chromium molybdenum(CoCrMo) alloy. The uni femoral heads have an internal taper which mates with ataper sleeve adapter. The femoral heads articulate with the corresponding one-piecemetal acetabular cups.

The taper sleeve adapters are manufactured from cobalt-chromium molybdenum(CoCrMo) alloy.

The DePuy Pinnacle'TM Metal-On-Metal (MOM) Acetabular Cup System is comprised ofa metal acetabular shell, a metal acetabular cup insert, and modular metal femoral heads.

The outer titanium aluminum vanadium (Ti-6A1-4V) alloy acetabular cup is a hemisphericalstepped and porous-coated shell with three dome screw holes, an apical hole used forvisualization, and a peripheral female taper. The Porocoat® porous coating on the shellis commercially pure titanium.

The superfinished metal liner is manufactured from cobalt-chromium molybdenum(CoCrMo) alloy. The metal insert mechanically locks with the metal shell via a taperjunction.

The modular heads are superfinished cobalt-chromium molybdenum (CoCrMo) alloymetal femoral heads. The metal femoral heads M-specification Articul/eze® cobalt-

16 6 1j

(b) (4)

chromium molybdenum (CoCrMo) alloy femoral heads with a 12/14 (Articul/eze) internaltaper, and S-ROM) M-Specification cobalt-chromium molybdenum (CoCrMo) alloy femoralheads with a 11/13 internal taper.

As there are no separate shell/liner components to the ASR system, the requested comparison ofthe shell/liner assembly/disassembly forces and the shell/liner locking mechanism is notapplicable.

4. b)Precliinical and clinical data addressing concerns associated with wear and fixationdue to the presence of HA couting or HA particulates and debris.

Response 4 b)Given the crystalline nature of the HA coating and the strength of attachment to theporous surface, we do not feel there is a well-developed mechanism of particulate releasefrom the shell OD into the periarticular tissue or synovial fluid to subsequently migrateinto the articular surface. DePuy is not aware of this phenomenon occurring in theclinical setting for HA coated metal-on-metal couples or HA coated metal-on-polyethylene couples.

In the situation where an HA particle would potentially be released from the acetabularshell and migrate into the articular region, it would likely be very small in order toadvance into the metal-on-metal articular space (less than , for ASRarticular surfaces). The potential exists for the smatler particle to pass through thearticular region, neither imbedding nor scratching the articular surfaces.

Alternatively, if the particle were larger than the clearance between the articular surfacesmaintained by the fluid film lubrication regime and became trapped within the articularsurfaces under the circumstances of microseparation, we believe that several thingswould occur:

- The very hard surfaces of the CoCrMo alloy would crush the weaker and brittle HAparticle creating much smaller sub-micron size particles allowing them to float freelyout of the surface and become resorbed by the body fluids.

- If a larger HA particle were to scratch the articular surface, we believe it would befractured and washed free of the articular surfaces and the scratch would eventuallyrepolish as metal-on-metal heads are known to do.

From the known clinical experience and laboratory testing we do not believe that theseparticles would cause degradation to the surface of the two hard, metal surfaces.

ct117

Exhibit 1

Test Report

18

(b) (4)

Confidential internal report

DePuy, Warsaw

0000019

(b) (4)

(b) (4)

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Confidential internal report Page 17 [/0o

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k040627, depuy orthopaedic, asr modular ace tabular cup system

Documents

good manufacturing

desire specific

ultima unipolar

ultima unipolar

congenital

multiple femoral

neck length

femoral head