JOURNEY™ IIActive Knee Solutions

*smith&nephew

Today’s fastest growing segment of knee replacement patients is seeking a return to a more active lifestyle.1

Traditional knee replacement options don’t meet the need for higher functionality, improved motion or long-term

durability.2,3,4,5

motion. Lack of motion, both selection and kinematics, can mean less satisfaction for patients who are unable to

return to the demanding activities of their active lifestyle. Surgeons are left tempering patient expectations and

tolerating the limited capabilities of traditional knee replacements.

The challenge

Controlsubjects

TKA patients

0 20 40 60 80 100

dancing

racquet sports

golf

carrying heavy objects

gardening

kneeling

squatting

Graph 1 2

Percent reporting no difficultyGraph 2 3

Sports activity

THA TKATHA

34%Post-op

42%Preop

52%Post-op

36%Preop

For orthopaedic surgeons seeking treatment solutions beyond

traditional knee replacements, JOURNEY™ II Active Knee Solutions

has been engineered to empower patients with a renewed right to

an active lifestyle by breaking through traditional knee replacement

barriers and delivers unmatched Function, Motion and Durability

through PHYSIOLOGICAL MATCHING Technology.

through function, motion and durability

The solution is

PHYSIOLOGICALMATCHING™ Technology

Function Stability

Anatomic, articular surfaces are designed to restore native anatomy and yield a normal anatomic A/P position throughout the range of motion.

• JOURNEY™ PFJ and JOURNEY UNI – Provide retention of the ACL and PCL allowing the native anatomy to provide its innate stability.

• JOURNEY II TKA – Provides a proper femoro-tibial A/P position yielding a virtual elimination of paradoxical

6-13

Normal Conventional JOURNEY II CR JOURNEY II BCS

Anterior stability – ACL function

Bi-Cruciate Stabilized

• ACL replicated by anterior cam-post interaction• Provides anterior stabilization during early gait (up to

• In contact only if needed• Has shown a 76% return to normal AP stability in the

original BCS design 14

MedialProminent posterior medial lip provides sta-bility and promotes normal kinematics

Normal AP sulcus position prevents paradoxical motion

Conventional AP sulcusRestores anatomic 3° distal and posterior femo-ral joint line and providing more normal ligament strain and patello-femoral tracking

Normal convexity provides increased posterior lateral slope to facilitate anatomic lateral femoral rollback and external rotation

Femur

the Patello-Femoral compartment

LateralSmaller anterior lateral lip allows screw home

JOURNEY II BCS Knee Systemwith PHYSIOLOGICAL MATCHING

Conventional TKA

Strength

the proper A/P positioning, thereby preventing muscle fatigue during activities of daily living.

• JOURNEY™ PFJ and JOURNEY UNI – Restores patients’ strength by replacing only the isolated, diseased portion of the knee allowing anatomic A/P alignment for the native anatomy to function as it had before surgery.

• JOURNEY II TKA – Restoration of both the anatomic A/P alignment and the normal kinematic patterns of the knee should produce more normal neuromuscular

demonstrated in the original BCS design.10, 15

Satisfaction (Proprioception)

Improving patients’ ease of activities of daily living can be expected due to the anticipated improvements of strength and stability.

• JOURNEY PFJ and JOURNEY UNI – The preservation of the natural structures (ACL and PCL) is preferred by patients. 16, 17

• JOURNEY II TKA – Restoration of more normal neu-

motion should improve a patient’s ability to perform the

original JOURNEY BCS design.18, 19

2x increase In Quad Activity Virtually Identical Quad Activity

EMG Data 5

CR TKA Normal knee BCS TKA Normal knee0

27.5

55

82.5

110

0

27.5

55

82.5

110

Lachman test JOURNEY TKA patients

Normal < 2mm Abnormal > 2mm0

3

6

9

12

1516

Num

ber o

f pat

ient

s

Num

ber o

f pat

ient

s

Num

ber o

f pat

ient

s

I

Motion Tibiofemoral (TF) kinematics The kinematic patterns of the femur and tibia of a knee design have a direct impact on patients’

reported levels of satisfaction with the outcomes of their knee replacements.19, 20 Extension• Femur internally rotated to achieve a natural anatomic screw-home position • Minimal posterior femoral overhang in the sagittal plane (Proper A/P position)

in high demand activities

Extension

Normal Knee 21

(Right Knee)JOURNEY™ BCS

(Left Knee)Conventional PS

(Left Knee)

Mid-Flexion

Deep-Flexion

FDA Claim Details

JOURNEY™ BCS replicates the motion patterns of the normal, healthy knee 6, 7, 8, 9, 10, 11, 12, 13, 21

51015

-15-10-5

51015

-15-10-5

51015

-15-10-5

FFFFFFDFDFDFDDDDADAAAFDFDFDDFFDFDAFFFDF ClClClClaaimaimaima m DDDDDeDeDeDeDeDeDeDeDeDeDeeeeeeeeeeeDeeeeeeeeeeeeeeeeeeetttttaittttttttttttttt

51015

-15-10-5

51015

-15-10-5

51015

-15-10-5

1357911

1357911

1357911

0

Degree

15

30

45

60

75

90

105

120

MAX

LateralLateral MedialMedial

LateralMedial

LateralMedial

Lateral Medial

Lateral Medial Lateral Medial

Lateral Medial Lateral Medial

Patellofemoral (PF) kinematics

The kinematic pattern in the PF joint is critically impor-tant to decrease anterior knee pain post operatively and the associated revisions.22, 23, 24, 25

• Provides improved contact which should improve wear performance 22

• Provides improved patella tracking which should minimize anterior pain 22, 23

• Provides more freedom of baseplate positioning without maltracking concerns 26

Flexion

The normal kinematic patterns of movement provide the

performance.

• JOURNEY™ PFJ and JOURNEY UNI – Designed to preserve the normal anatomy of the knee, therefore promoting a more natural range of motion.

• JOURNEY II TKA – Engineered to provide for up to 155°

JOURNEY BCS. 6, 9, 11, 13, 14, 28, 29

Conventional PS TKAJOURNEY II TKAIn Vivo 27

In Vivo +std devInv Vivo -std dev

DurabilityCombining the award-winning materials of OXINIUM™ Oxidized Zirconium and highly cross-linked polyethylene (XLPE), Smith & Nephew was able to create VERILAST™ Technology, a highly durable and long-lasting material combination.Using this technology, JOURNEY™ II TKA is designed to match the same high standards for wear performance.

JOURNEY II CR

40

50

30

20

10

35

45

25

15

5

0

PFC Sigma3

0

GENESIS II31

Scorpi

o32

Triathl

on33

NexGen

34

Vangu

ard35

PFC Sigma3

0

GENESIS II31

Scorpi

o32

Triathl

on33

NexGen

34

Vangu

ard35

Attune

36

LEGIO

N TKS43

JOURNEY II

TKA37

non-detectibleVolu

met

ric w

ear r

ate

(mm

3 /Mcy

cle)

Graph 3VERILAST Technology vs Conventional Technology

23.00 23.45

34.60

20.20

24.40

43.40

5.40

13.00

6.41 7.30 6.504.10

6.10

Mean volumetric wear rates (+/- std. dev.) of CoCr against conventional polyethylene (CPE), CoCr against crosslinked polyethylene (XLPE) and OXINIUM against XLPE

CoCr and CPE CoCr and XLPE OXINIUM Technology on XLPE

0.58

Wear

• OXINIUM™ Oxidized Zirconium is an advanced bearing material that combines the strength of metal with the wear resistance of ceramics

• OXINIUM Technology is 4,900 times more resistant to abrasion than CoCr 38

• OXINIUM Technology is more than twice as hard as CoCr (Graph 4) 39

up to half that of CoCr (Graph 5) 40

• OXINIUM alloy femoral components are available for all JOURNEY™ II Active Knee Solutions products

Metal Sensitivity

We understand that no measurable nickel content is

• OXINIUM Oxidized Zirconium, exclusively from Smith & Nephew, addresses the needs of nickel sensitive patients by having less than 0.0035% nickel content, compared to a maximum content of 0.5% in cobalt chrome and 0.1% in titanium.

• Zirconium is a nearly inert material that has not reported to induce immune reactions.41

Graph 4Increased hardness

12

16

8

4

0

OXINIUM Alloy OXINIUM AlloyCoCr

Nan

ohar

dnes

s (G

Pa)

0.08

0.06

0.10

0.04

0.02

0

CoCr

Coef

ficie

nt o

f fric

tion

Graph 5Lower friction

12.1

5.40.04

0.08

JOURNEY II BCS

JOURNEY PFJJOURNEY UNI

Patented the usage of Oxidized Zirconium with orthopaedic medical devices

The introduction of the GENESIS TKS was a significant step in the evolution of the modern knee designs. It was the first system the “Address the Unexpected.” With a single set of instruments and implants, virtually any interoperative situation could be handled. This technological advancement greatly simplified the process of TKA.Designers: Dr. Ramon Gustilo, Dr. Jim Rand, Dr. Richard Laskin, Dr. James Howe, and Dr. Todd Swanson.

Launched as one of the first asymmetric femoral component designs, opening up the opportunity for less traditional knee designs. Over 1 million GENESIS II knees have been implanted globally.

The first OXINIUM Alloy total knee implantation. Over the past 15 + years over 600k OXINIUM Alloy hips and knees have been implanted worldwide

Richards Manufacturing collaborate with Dr. Leonard Marmor to commercially produce the first unicondylar knee on the market.

1988 GENESIS™ Total Knee System

1991 OXINIUM Oxidized

Zirconium Patented

1995 GENESIS UNI

The JOURNEY PFJ combines the clinically proven performance of its trochlear groove with powerful precision-the first completely instrumented JOURNEY PFJ system for greater reproducibility and ease of use. Designers: Dr. John Neuman, FRCS, William B. Smith, MD, E. Lyle, Dr. E. Lyle Cain Jr., and Dr. Jeffrey R. Dugas

Engineering Materials Achievement Awarded to Smith & Nephew for use of OXINIUM Oxidized Zirconium. Established in 1969, this award recognizes an outstanding achievement in materials or materials systems relating to the application of knowledge of materials to an engineering structure or to the design and manufacture of a product. Smith & Nephew is only orthopaedics company to ever win this award. Past recipients include: GE, DuPont, IBM, Texas Instruments, Dow Corning, Northrup Grumman

1997 GENESIS II Total Knee System

Using advanced biomechanical modeling technologies; the JOURNEY BCS was the first TKA to accurately replicate the normal kinematic patterns of the healthy knee joint. Over 60,000 JOURNEY BCS knees have been implanted around the world. Designers: Prof. Johan Bellemans, Dr. Jonathan Garino, Dr. Steven Haas, Dr. Michael Ries, and Prof. Jan Victor.

2005 JOURNEY™ BCS

The LEGION Revision Knee System was designed to strike a perfect balance by providing simple, efficient instruments specific to revision and a broad range of implant options to address even the most demanding surgeries. Combined with Oxidized Zirconium, LEGION Revision helps surgeons give their patients the potential for better outcomes with lower wear.

2005 LEGION™ Revision Knee (RK)

2005

2006 JOURNEY PFJ

1970 1980 1990 2000

Innovating for the lifecycle

Following on a rich history of partial knee arthroplasty

and success of the JOURNEY™ BCS design – which

showed recovery of normal patterns of motion and high

gains in flexion 6-13, 21, 27-28 – Smith & Nephew has created

a seamless, next generation family of partial and

primary knee designs intended to restore patients to an

unmatched level of function, motion and durability.

1972 Richards Manufacturing Company Marmor Uni

GENESIS UNI launched in collaboration with Professor Cartier and Dr. James Andrews has demonstrated to be one of the most clinically successful unicondylar knees on the market (94.5% at 10 years).41

VERILAST Technology, a one-of-a-kind advanced bearing couple of OXINIUM Oxidized Zirconium with highly-crosslinked polyethylene formulation designed specifically for knees.

JOURNEY UNI knee treats isolated compartmental disease with anatomic components coupled with simple, intuitive instrumentation for a streamlined, reproducible technique. Designers: Dr. William Bugbee, Dr. Donald Polakoff, Dr. Jonathan Young, Dr. Stuart Smith, Dr. Douglas Naudie, Dr. Paul Saenger, Dr. Jerome Rubini

In 2009 Smith & Nephew globally launched the foundation of its patient specific solutions, VISIONAIRE Patient Matched Cutting blocks. Smith & Nephew was the first company to launch patient matched technology developed and manufactured completely in house.

The next generation of normal function, motion and durability. More normal kinematics and function-strength, stability and higher flexion achieved through the unique features of the JOURNEY II BCS system; normal shapes, normal position and normal motion. Designers: Prof. Johan Bellemans, Dr. Jonathan Garino, Dr. Steven Haas, Dr. Michael Ries, and Prof. Jan Victor, Dr. Mark Snyder and Dr. Fred Cushner.

2012 JOURNEY II BCS

Revolutionary approach to addressing medial femoral and patella-femoral disease in monolithic component. The lessons gained from experiences have allowed advanced kinematic evaluations. Designers: Dr. Lindsey Rolston and Dr. Gerard Engh.

2008 JOURNEY UNI

2007 JOURNEY™ DEUCE™

Smith & Nephew purchased the Swiss company PLUS Orthopedics. This added the PLUS SOLUTION KNEE FAMILY to the portfolio: TC-PLUS PRIMARY™, TC-PLUS™ REVISION, and RT-PLUS™ REVISION. The PLUS Knee family is developed and manufactured in Switzerland and offers a seamless system; from Primary – Complex Primary – Revision – Hinge Knee.

2007 PLUS Orthopedics

2008 Launched VERILAST™ Technology

2009 VISIONAIRE™ Patient Matched Instrumentation

LEGION Hinged Knee is launched as an extension of the clinically successful LEGION Total Knee System. Its kinematic and bone sparing design not only alleviates patients’ symptoms, but also restores an almost natural knee function. Coupled with its ease of use by allowing surgeons to seamlessly transition intraoperatively from a constrained revision implant to a hinged assembly, it makes knee salvage, knee rescue.

2012 LEGION™ Hinge (HK)

Smith & Nephew announces the acquisition of LifeModeler, Inc. (LMI), the leading provider of biomechanical human body simulation tools and services.LMI’s groundbreaking software shortens the time taken to develop new products by enabling the evaluation of innovations in a virtual model of the human body. New orthopaedic products can be tested and validated faster, further and more cost effectively prior to the production of a physical prototype.

2012 Acquisition of LifeMod

2010

Designed to be the first kinematically correct cruciate retaining TKA on the market designed in collaboration with Professor Johan Bellemans, Dr. David Drucker, Dr. Alois Franz, Dr. Murali Jasty, Dr. Gerald Jerry, Dr. Michael Ries, Mr. Neil Thomas, Dr. Alfred Tria, Professor Jan Victor and Dr. Ate Wymenga

In 2013 Smith & Nephew launched its first phase of Patient Specific Logistics with the Universal Instrument Trays. This industry leading initiative allows for Smith & nephew to provide “just in time logistics” where instruments specific to each patient including size and hand are provided for each surgery helping to reduce hospital costs and improve operating room efficiency.

2013 VISIONAIRE

Technology and Patient

Specific Logistics

2014 JOURNEY II CR

Smith & Nephew, Inc.7135 Goodlett Farms Parkway Cordova, TN 38016 USA

Telephone: 1-901-396-2121 Information: 1-800-821-5700 Orders and Inquiries: 1-800-238-7538

™Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office. All Trademarks acknowledged.

www.smith-nephew.com

©2013 Smith & Nephew, Inc. 7128-1992 REVA 3/13

References

1. US Department of Health and Human Services Agency (HHSA) for Healthcare Research and Quality (AHRQ) Knee Replacements Up Dramatically Among Adults 45 to 64 Years Old. AHRQ News and Numbers, November 3, 2011. Agency for Healthcare Research and Quality, Rockville, MD.

2. Phil Noble et al; Does total knee replacement restore normal knee function? 2005; CORR. (431): 157-65.3. Huch K, Müller KA, Stürmer T, Brenner H, Puhl W, Günther KP. Sports activities 5 years after total knee or hip arthroplasty: the Ulm Osteoarthritis Study. Ann Rheum Dis. 2005 Dec; 64 (12):1715-20.4. Comparing patient outcomes after THA and TKA: is there a difference? Bourne RB, Chesworth B, Davis A, Mahomed N, Charron K. Clin Orthop Relat Res. 2010 Feb; 468(2):542-6. Epub

2009 Sep 4.

-dic Research Society. 2009; Paper No. 2067.

13. Van Duren BH, Pandit H, Price M, Tilley S, Gill HS, Murray DW, Thomas NP. Bicruciate substituting total knee replacement: how effective are the added kinematic constraints in vivo? Knee Surg Sports Traumatol Arthrosc. 2012 Oct; 20 (10):2002-10. Epub 2011 Nov 29.

Med Eng Technol. 2009;33(8):610-5.

2009 Aug 31.

Biomech, 2005;38(2):357-365.

2007, 0021.

36. Ref: DePuy Attune 510 K Document K101433 Dec 10, 201037. Ref: Smith & Nephew OR-12-129

2000, p. 835.

Smith & Nephew, Inc.7135 Goodlett Farms Parkway Cordova, TN 38016 USA

Telephone: 1-901-396-2121 Information: 1-800-821-5700 Orders and Inquiries: 1-800-238-7538

™Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office. All Trademarks acknowledged.

www.smith-nephew.com

©2013 Smith & Nephew, Inc.

References

1. US Department of Health and Human Services Agency (HHSA) for Healthcare Research and Quality (AHRQ) Knee Replacements Up Dramatically Among Adults 45 to 64 Years Old. AHRQ News and Numbers, November 3, 2011. Agency for Healthcare Research and Quality, Rockville, MD.

2. Phil Noble et al; Does total knee replacement restore normal knee function? 2005; CORR. (431): 157-65.3. Huch K, Müller KA, Stürmer T, Brenner H, Puhl W, Günther KP. Sports activities 5 years after total knee or hip arthroplasty: the Ulm Osteoarthritis Study. Ann Rheum Dis. 2005 Dec; 64 (12):1715-20.4. Comparing patient outcomes after THA and TKA: is there a difference? Bourne RB, Chesworth B, Davis A, Mahomed N, Charron K. Clin Orthop Relat Res. 2010 Feb; 468(2):542-6. Epub

2009 Sep 4.5. Functional comparison of posterior cruciate-retained versus cruciate-sacrificed total knee arthroplasty. Dorr LD, Ochsner JL, Gronley J, Perry J. Clin Orthop Relat Res. 1988 Nov; (236):36-43.6. Victor J, Mueller JK, Komistek RD, Sharma A, Nadaud MC, Bellemans J. In vivo kinematics after a cruciate-substituting TKA. Clin Orthop Relat Res. 2010 Mar; 468(3):807-14.7. Zingde SM, Sharma A, Komistek RD, Dennis, DA, Mahfouz, MR. In vivo comparison of kinematics for 1891 non-implanted and implanted knees. AAOS. 2009; Scientific Exhibit No. 22.8. Zingde SM, Mueller J, Komistek RD, MacNaughton JM, Anderle MR, Mauhfouz MR. In vivo comparison of tka kinematics for subjects having a PS, PCR, or Bi-Cruciate Stabilizing design. Orthope-

dic Research Society. 2009; Paper No. 2067.9. Bicruciate-stabilised total knee replacements produce more normal sagittal plane kinematics than posterior-stabilised designs.Ward TR, Burns AW, Gillespie MJ, Scarvell JM, Smith PN J Bone

Joint Surg Br. 2011 Jul;93(7):907-13. 10. Catani F, Ensini A, Belvedere C, Feliciangeli A, Benedetti MG, Leardini A, Giannini S. In vivo kinematics and kinetics of a bi-cruciate substituting total knee arthroplasty: a combined fluoroscopic

and gait analysis study. J Orthop Res. 2009 Dec;27(12):1569-75.11. Morra EA, Rosca M, Greenwald JFI, Greenwald AS. The influence of contemporary knee design on high flexion: a kinematic comparison with the normal knee. JBJS Am. 2008; 90: 195-201.12. The Mark Coventry Award: Articular contact estimation in TKA using in vivo kinematics and finite element analysis. Catani F, Innocenti B, Belvedere C, Labey L, Ensini A, Leardini A. Clin Orthop

Relat Res. 2010 Jan; 468(1):19-28. doi: 10.1007/s11999-009-0941-4. Epub 2009 Jun 23.13. Van Duren BH, Pandit H, Price M, Tilley S, Gill HS, Murray DW, Thomas NP. Bicruciate substituting total knee replacement: how effective are the added kinematic constraints in vivo? Knee Surg

Sports Traumatol Arthrosc. 2012 Oct; 20 (10):2002-10. Epub 2011 Nov 29.14. Arbuthnot JE, Brink RB. Assessment of the antero-posterior and rotational stability of the anterior cruciate ligament analogue in a guided motion bi-cruciate stabilized total knee arthroplasty. J

Med Eng Technol. 2009;33(8):610-5.15. Lester DK and Shantharam R. Objective Sagittal Instability of CR-TKA by Functional EMG During Normal Walking. AAOS. 2012; Presentation No. 810.16. Pritchett JW. Patient preferences in knee prostheses. J Bone Joint Surg Br. 2004 Sep; 86(7):979-82.17. Pritchett JW. Anterior cruciate-retaining total knee arthroplasty. J Arthroplasty. 1996 Feb; 11(2):194-7.18. Rajgopal A; Dahiya V; Kochhar H. Bi-Cruciate Substituting Total Knee Arthroplasty Early Experience. International Society for Technology in Arthroplasty: 22 Congress. 2009; Poster No. 107.19. Haas S. Kinematics of the Knee & JOURNEY BCS. Insall Club Annual Meeting. June 201020. Banks SA; Fregly BJ; Boniforti F; Reinschmidt C; Romagnoli S. Comparing in vivo kinematics of unicondylar and bi-unicondylar knee replacements. Knee Surg Sports Traumatol Arthrosc. 2005

Oct; 13(7):551-6. Epub 2005 Jan 20.21. Mahfouz MR, Komistek RD, Dennis DA, Hoff WA. In vivo assessment of the kinematics in normal and anterior cruciate ligament-deficient knees. J Bone Joint Surg Am. 2004;86-A Suppl 2:56-61.22. Carpenter RD, et al, Magnetic resonance imaging of in vivo patellofemoral kinematics after total knee arthroplasty, The Knee (2009), doi:10.1016/j.knee.2008.12.01623. Brilhault J, Ries MD. Measuring patellar height using the lateral active flexion radiograph: Effect of total knee implant design. Knee. 2010 Mar;17(2):148-51. doi: 10.1016/j.knee.2009.07.008. Epub

2009 Aug 31.24. Leopold SS, Silverton CD, Barden RM, Rosenberg AG. Isolated revision of the patellar component in total knee arthroplasty. J Bone Joint Surg Am 2003; 85-A:41–7.25. Breugem SJ, van Ooij B, Haverkamp D, Sierevelt IN, van Dijk CN. No difference in anterior knee pain between a fixed and a mobile posterior stabilized total knee arthroplasty after 7.9 years. Knee

Surg Sports Traumatol Arthrosc. 2012 Nov 3. [Epub ahead of print] (http://www.ncbi.nlm.nih.gov/pubmed/23124601)26. Lee GC, Garino JP, Kim RH, Lenz N. Contributions of Femoral, Tibial and Patellar Malposition to Patellar Maltracking in Total Knee Arthroplasty. AAOS. 2013; Poster No. 11427. Nha KW, Papannagari R, Gill TJ, Van de Velde SK, Freiberg AA, Rubash HE, Li G. In vivo patellar tracking: clinical motions and patellofemoral indices. J Orthop Res. 2008 Aug;26(8):1067-74.28. Victor J, Ries M, Bellemans J, Robb WM, Van Hellemondt G. High-flexion, motion-guided total knee arthroplasty: who benefits the most? Orthopedics. 2007 Aug; 30 (8 Suppl): 77–9.29. Kuroyanagi Y, Mu S, Hamai S, Robb WJ, Banks SA. In vivo knee kinematics during stair and deep flexion activities in patients with bicruciate substituting total knee arthroplasty. J Arthroplasty.

2012 Jan; 27(1):122-8. doi: 10.1016/j.arth.2011.03.005. Epub 2011 Apr 19.30. H. M. J. McEwen, P. I. Barnett, C. J. Bell, R. Farrar, D. D. Auger, M. H. Stone and J. Fisher, The influence of design, materials and kinematics on the in vitro wear of total knee replacements, J

Biomech, 2005;38(2):357-365.31. A. Parikh, M. Morrison and S. Jani, Wear testing of crosslinked and conventional UHMWPE against smooth and roughened femoral components, Orthop Res Soc, San Diego, CA, Feb 11-14,

2007, 0021.32. AA. Essner, L. Herrera, S. S. Yau, A. Wang, J. H. Dumbleton and M. T. Manley, Sequentially crosslinked and annealed UHMWPE knee wear debris, Orthop Res Soc, Washington D.C., 2005, 71.33. L. Herrera, J. Sweetgall, A. Essner and A. Wang, “Evaluation of sequentially crosslinked and annealed wear debris, World Biomater Cong, Amsterdam, May 28-Jun 1, 2008, 583.34. C. Schaerer, K. Mimnaugh, O. Popoola and J. Seebeck, “Wear of UHMWPE tibial inserts under simulated obese patient conditions,” Orthop Res Soc, New Orleans, LA, Feb 6-10, 2010, 2329.35. Biomet publication, FDA Cleared Claims for E1 Antioxidant Infused Technology” 36. Ref: DePuy Attune 510 K Document K101433 Dec 10, 201037. Ref: Smith & Nephew OR-12-129 38. Hunter, G., and Long, M. Abrasive Wear of Oxidized Zr-2.5Nb, CoCrMo, and Ti-6Al-4V Against Bone Cement. 6th World Biomaterials Cong. Trans., Society for Biomaterials, Minneapolis, MN,

2000, p. 835.39. Long, M., Riester, L., and Hunter, G. no-hardness Measurements of Oxidized Zr-2.5Nb and Various Orthopaedic Materials. Trans. Soc. Biomaterials, 21, 1998, p. 528.40. Poggie RA, Wert J, Mishra A, et al (1992). Friction and wear characterization of UHMWPE in reciprocating sliding contact with Co-Cr, Ti-6Al-4V, and zirconia implant bearing surfaces. Wear and

Friction of Elastomers, Denton R and Keshavan MK, Eds., West Conshohocken, PA: ASTM International.41. Nasser, S.: Biology of Foreign Bodies: Tolerance, Osteolysis and Allergy in Total Knee Arthroplasty, Edited by J. Bellemans, M.D. Ries and J. Victor; Springer -Verlag, Heidelberg, 200542. Cartier P, Khefacha A, Sanouiller JL, Frederick K. Unicondylar knee arthroplasty in middle-aged patients: a minimum 5-year follow-up. Orthopedics. 2007 Aug; 30 (8 Suppl):62-5. 43. R. Papannagari, G. Hines, J. Sprague and M. Morrison, “Long-term wear performance of an advanced bearing knee technology,” ISTA, Dubai, UAE, Oct 6-9, 2010.

00742 V1 09/13