U.S. Food & Drug Administration

10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 4 . 1 4

Silver Spring, MD 20993

www.fda.gov

March 11, 2020

KLS-Martin L.P.

Pam Martin

Regulatory Affairs Project Manager

11201 Saint Johns Industrial Parkway S

Jacksonville, Florida 32246

Re: K192979

Trade/Device Name: KLS Martin Individual Patient Solutions (IPS) Planning System

Regulation Number: 21 CFR 888.3030

Regulation Name: Orthopaedic Surgical Planning and Instrument Guides

Regulatory Class: Class II

Product Code: PBF, LLZ

Dated: December 6, 2019

Received: December 12, 2019

Dear Pam Martin:

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. Although this letter refers to your product as a device, please be aware that

some cleared products may instead be combination products. The 510(k) Premarket Notification Database

located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination

product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We

remind you, however, that device labeling must be truthful and not misleading.

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

subject to 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

K192979 - Pam Martin Page

2

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for

combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part

807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part

803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-

mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including

information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-

devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn

(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE

by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, MPH

Assistant Director

DHT6C: Division of Restorative, Repair

and Trauma Devices

OHT6: Office of Orthopedic Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.

510(k) Number (if known)K192979

Device Name KLS Martin Individual Patient Solutions (IPS) Planning System

Indications for Use (Describe) The KLS Martin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the IPS Planning System and the result is an output data file that may then be provided as digital models or used in an additive manufacturing portion of the system that produces physical outputs including anatomical models, guides, and case reports for use in thoracic (excluding spine) and reconstructive surgeries. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

Type of Use (Select one or both, as applicable)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov

“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.”

11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 Phone: 904-641-7746 800-625-1557 Fax: 904-641-7378 www.klsmartinnorthamerica.com

K192979 510(k) Summary

21 CFR 807.92

Submitter:

Contact Person:

Date Prepared:

Trade Name:

Common Name:

Classification Name:

Regulatory Class:

Product Codes:

Regulation Number:

Primary Predicate:

Reference Devices:

KLS-Martin L.P. 11201 Saint Johns Industrial Pkwy S. Jacksonville, FL 32246

Pam Martin, RAC, MSc Regulatory Affairs Project Manager Phone: 800-625-1557Email: pmartin@klsmartinusa.com

December 6, 2019

KLS Martin Individual Patient Solutions (IPS) Planning System

System for the creation of patient specific anatomical models, cutting/marking guides, and case reports

Orthopaedic Surgical Planning and Instrument Guides; System, Image Processing, Radiological

II

PBF, LLZ

21 CFR 888.3030, 21 CFR 892.2050 KLS Martin IPS Planning System (K182789)

KLS Martin IPS Planning System (K181241) KLS Martin Individual Patient Solutions (K163579) KLS Martin Thoracic Plating System (K153482)

Device Description The KLS Martin Individual Patient Solutions (IPS) Planning System is a collection of software and associated additive manufacturing equipment intended to provide a variety of outputs to support thoracic (excluding spine) and reconstructive surgeries. The system uses electronic medical images of the patients’ anatomy (CT data) with input from the physician, to manipulate original patient images for planning and executing surgery. The system processes the medical images and produces a variety of patient specific physical and/or digital output devices which include anatomical models, guides, and case reports.

Indications for Use The KLS Martin Individual Patient Solutions (IPS) Planning System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the IPS Planning System and the result is an output data file that may then be provided as digital models or used in an additive manufacturing portion of the system that produces physical outputs including anatomical models, guides, and case reports for use in thoracic (excluding spine) and reconstructive surgeries. The IPS Planning System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

Page 1 of 10

11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 Phone: 904-641-7746 800-625-1557 Fax: 904-641-7378 www.klsmartinnorthamerica.com

Technological Characteristics/Substantial Equivalence Discussion: The intended use of the subject device, KLS Martin Individual Patient Solutions (IPS) Planning System, is identical to the primary predicate device, the KLS Martin Individual (IPS) Patient Solutions System (K182789):

The subject and primary predicate devices are intended for use as a software and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed through the virtual planning software systems and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs. These physical outputs can be anatomical models, guides, and case reports. All digital data and physical devices are used to aid the surgeon during reconstructive surgeries. They are both also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

The indications for use statement of the subject device differs in anatomical location and system outputs from the primary predicate, K182789. K182789 is cleared for use in maxillofacial surgery. The subject device is indicated for thoracic (excluding spine) surgery.

The potential impact on substantial equivalence for each technological difference has been addressed through risk analysis as well as verification and validation testing.

Similarities to Predicate The subject and primary predicate devices share the same fundamental principle of operation – a system that processes original patient medical images (i.e., CT scan) and produces avariety of patient-specific physical and/or digital output devices for planning and executingsurgery.

The subject device shares identical technological characteristics as the primary predicate regarding software, material composition, biocompatibility, manufacturing process, performance testing, as well as cleaning and sterilization.

Both the subject and primary predicate devices use image data obtained from medical scanners, such as a CT scan. The subject device utilizes two (2) commercially off-the-shelf (COTS) software applications for image segmentation and manipulation identical to what was evaluated in the primary predicate device, K182789. The validated commercially off-the-shelf (COTS) software applications are used to transfer patient imaging from a DICOM format to a .STL format and manipulate the images to produce a final design file. In addition, both devices require trained employees/engineers who utilize the software applications to manipulate data and work with the physician to create the virtual planning session. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the trained employee/engineer during the planning session.

Both systems use additive manufacturing methods to produce physical output devices that include patient-specific anatomical models and guides. In addition, the systems produce digital models and case reports for the physician to use for planning surgeries or to use during surgery.

Materials used in the manufacture of the subject output devices are synthetic polymers, acrylic resins, and titanium (CP titanium & Titanium Alloy), which are identical to what was evaluated in the primary predicate device, K182789.

Page 2 of 10

K192979

11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 Phone: 904-641-7746 800-625-1557 Fax: 904-641-7378 www.klsmartinnorthamerica.com

All output devices from both systems are provided non-sterile and must be sterilized by the end user prior to use. Steam sterilization validation studies were performed to ensure a sterility assurance level (SAL) of 10-6.

Differences from Predicate The subject device’s indications for use differs from the primary predicate in anatomical region. The skeletal region for which the primary predicate device was cleared includes the mandibular and maxillofacial areas. The subject device will be used in the thoracic region (excluding spine).

Previously cleared specifications for the primary predicate were expanded for the subject device guides based on differences in anatomical region. The maximum thickness of the subject device guides is 20 mm to allow for thickening of areas that guide drilling or cutting paths in the thoracic region. The primary predicate devices in the maxillofacial region pose a greater challenge in terms of limited surgical access, whereas the anatomy of the thoracic region is relatively unobstructed. The increase in thickness for the subject device guides was analyzed for additional risk compared to the primary predicate. The results of the dimensional analysis for the subject device compared to the primary predicate device did not indicate new or different questions of risk or safety and effectiveness. Simulated use of guides intended for use in the thoracic region was validated by means of virtual planning sessions with the end-user.

The primary predicate device utilizes four (4) pieces of software that is a combination of COTS and custom to fabricate physical outputs specific to maxillofacial surgeries, including orthognathic splints). The subject device only requires two of the four software applications used by the predicate in order to produce anatomical models, guides, and case reports. Splints are for orthognathic use only and not applicable to this submission.

The primary predicate patient population includes all pediatric subpopulations (neonate, infant, child, adolescent) and adults, whereas the subject device limits the pediatric subpopulations to child and adolescent, but still includes the adult population.

A risk assessment has been performed based on FDA guidance, “Premarket Assessment of Pediatric Medical Devices, March 24, 2014” for these subpopulations with supporting peer-reviewed clinical literature to demonstrate the safety and effectiveness of the subject device for use in the pediatric subpopulations.

Reference Devices

KLS Martin Individual Patient Solutions (K163579) and the KLS Martin IPS Planning System (K181241) have been included as reference devices to leverage performance testing regarding the material composition (material recycling process, degradation, tensile & bending). Subject devices are manufactured from identical materials, undergo the same manufacturing processes, have the same biocompatibility, demonstrate similar performance characteristics, and are designed, verified, cleaned and sterilized using the same validated methods as the reference devices cleared in K163579 and K181241.

The KLS Martin Thoracic Plating System, K153482, has been included as a reference device to address differences in technological characteristics between the subject and primary predicate devices.

Page 3 of 10

K192979

11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 Phone: 904-641-7746 800-625-1557 Fax: 904-641-7378 www.klsmartinnorthamerica.com

Anatomy: The primary predicate device was cleared for use in the maxillofacial skeleton, including mandible, whereas the subject device is indicated for the thoracic region (excluding spine), which is identical to the reference device.

Fixation screws: The primary predicate screws range from 1.5 mm – 2.7 mm in diameter with lengths of 4 mm – 22 mm, whereas the subject device screws range from 2.3 mm – 3.2mm in diameter with lengths from 7 mm – 17 mm, which is identical to what was cleared in the reference device.

Page 4 of 10

K192979

1120

1 Sa

int J

ohns

Indu

stria

l Pkw

y S

Jack

sonv

ille,

FL

3224

6 Ph

one:

904

-641

-774

6 8

00-6

25-1

557

Fax

: 904

-641

-737

8 w

ww

.kls

mar

tinno

rtham

eric

a.co

m

KL

S M

artin

IPS

Plan

ning

Sy

stem

(Sub

ject

Dev

ice)

KL

S M

artin

IPS

Plan

ning

Sy

stem

K

1827

89

(Pri

mar

y Pr

edic

ate)

KL

S M

artin

IPS

Plan

ning

Sy

stem

K

1812

41

(Ref

eren

ce D

evic

e)

KL

S M

artin

Indi

vidu

al

Patie

nt S

olut

ions

K

1635

79

(Ref

eren

ce D

evic

e)

KL

S M

artin

Tho

raci

c Pl

atin

g Sy

stem

K

1534

82

(Ref

eren

ce D

evic

e)

Indi

catio

ns fo

r U

se

The

KLS

Mar

tin In

divi

dual

Pa

tient

Sol

utio

ns (I

PS)

Plan

ning

Sys

tem

is in

tend

ed

for u

se a

s a so

ftwar

e sy

stem

an

d im

age

segm

enta

tion

syst

em fo

r the

tran

sfer

of

imag

ing

info

rmat

ion

from

a

med

ical

scan

ner s

uch

as a

CT

base

d sy

stem

. The

inpu

t dat

a fil

e is

pro

cess

ed b

y th

e IP

S Pl

anni

ng S

yste

m a

nd th

e re

sult

is a

n ou

tput

dat

a fil

e th

at m

ay th

en b

e pr

ovid

ed a

s di

gita

l mod

els o

r use

d in

an

addi

tive

man

ufac

turin

g po

rtion

of t

he sy

stem

that

pr

oduc

es p

hysi

cal o

utpu

ts

incl

udin

g an

atom

ical

mod

els,

guid

es, a

nd c

ase

repo

rts fo

r us

e in

thor

acic

(exc

ludi

ng

spin

e) a

nd re

cons

truct

ive

surg

erie

s. Th

e IP

S Pl

anni

ng

Syst

em is

als

o in

tend

ed a

s a

pre-

oper

ativ

e so

ftwar

e to

ol

for s

imul

atin

g / e

valu

atin

g su

rgic

al tr

eatm

ent o

ptio

ns.

The

KLS

Mar

tin In

divi

dual

Pa

tient

Sol

utio

ns (I

PS)

Plan

ning

Sys

tem

is in

tend

ed

for u

se a

s a so

ftwar

e sy

stem

an

d im

age

segm

enta

tion

syst

em fo

r the

tran

sfer

of

imag

ing

info

rmat

ion

from

a

med

ical

scan

ner s

uch

as a

CT

base

d sy

stem

. The

inpu

t dat

a fil

e is

pro

cess

ed b

y th

e IP

S Pl

anni

ng S

yste

m a

nd th

e re

sult

is a

n ou

tput

dat

a fil

e th

at m

ay th

en b

e pr

ovid

ed a

s di

gita

l mod

els o

r use

d as

in

put t

o a

rapi

d pr

otot

ypin

g po

rtion

of t

he sy

stem

that

pr

oduc

es p

hysi

cal o

utpu

ts

incl

udin

g an

atom

ical

mod

els,

guid

es, s

plin

ts, a

nd c

ase

repo

rts fo

r use

in

max

illof

acia

l sur

gery

. The

IP

S Pl

anni

ng S

yste

m is

als

o in

tend

ed a

s a p

re-o

pera

tive

softw

are

tool

for s

imul

atin

g /

eval

uatin

g su

rgic

al tr

eatm

ent

optio

ns.

The

KLS

Mar

tin In

divi

dual

Pa

tient

Sol

utio

ns (I

PS)

Plan

ning

Sys

tem

is in

tend

ed

for u

se a

s a so

ftwar

e sy

stem

an

d im

age

segm

enta

tion

syst

em fo

r the

tran

sfer

of

imag

ing

info

rmat

ion

from

a

med

ical

scan

ner s

uch

as a

CT

base

d sy

stem

. The

inpu

t dat

a fil

e is

pro

cess

ed b

y th

e IP

S Pl

anni

ng S

yste

m a

nd th

e re

sult

is a

n ou

tput

dat

a fil

e th

at m

ay th

en b

e pr

ovid

ed a

s di

gita

l mod

els o

r use

d as

in

put t

o a

rapi

d pr

otot

ypin

g po

rtion

of t

he sy

stem

that

pr

oduc

es p

hysi

cal o

utpu

ts

incl

udin

g an

atom

ical

mod

els,

guid

es, s

plin

ts, a

nd c

ase

repo

rts fo

r use

in

max

illof

acia

l sur

gery

. The

IP

S Pl

anni

ng S

yste

m is

als

o in

tend

ed a

s a p

re-o

pera

tive

softw

are

tool

for s

imul

atin

g /

eval

uatin

g su

rgic

al tr

eatm

ent

optio

ns.

KLS

Mar

tin In

divi

dual

Pat

ient

So

lutio

ns im

plan

t dev

ices

are

in

tend

ed fo

r use

in th

e st

abili

zatio

n an

d fix

atio

n of

m

andi

bula

r fra

ctur

es a

nd

man

dibu

lar r

econ

stru

ctio

n.

The

KLS

Mar

tin T

hora

cic

Fixa

tion

Syst

em is

in

dica

ted

for u

se in

the

stab

iliza

tion

and

fixat

ion

of fr

actu

res i

n th

e ch

est

wal

l inc

ludi

ng st

erna

l re

cons

truct

ive

surg

ical

pr

oced

ures

, tra

uma,

or

plan

ned

oste

otom

ies.

Page 5 of 10

K192979

1120

1 Sa

int J

ohns

Indu

stria

l Pkw

y S

Jack

sonv

ille,

FL

3224

6 Ph

one:

904

-641

-774

6 8

00-6

25-1

557

Fax

: 904

-641

-737

8 w

ww

.kls

mar

tinno

rtham

eric

a.co

m

KL

S M

artin

IPS

Plan

ning

Sy

stem

(Sub

ject

Dev

ice)

KL

S M

artin

IPS

Plan

ning

Sy

stem

K

1827

89

(Pri

mar

y Pr

edic

ate)

KL

S M

artin

IPS

Plan

ning

Sy

stem

K

1812

41

(Ref

eren

ce D

evic

e)

KL

S M

artin

Indi

vidu

al

Patie

nt S

olut

ions

K

1635

79

(Ref

eren

ce D

evic

e)

KL

S M

artin

Tho

raci

c Pl

atin

g Sy

stem

K

1534

82

(Ref

eren

ce D

evic

e)

Con

trai

ndic

atio

ns

1.O

bvio

us in

fect

ions

.2.

Hyp

erse

nsiti

vity

to fo

reig

nbo

dies

.3.

Circ

ulat

ory

prob

lem

s,sy

stem

ic d

isea

ses,

and

met

abol

ic d

isor

ders

.4.

Insu

ffic

ient

or i

nade

quat

ebo

ne ti

ssue

.5.

Seco

ndar

y di

seas

es su

chas

deg

ener

ativ

e pr

oces

ses

that

may

neg

ativ

ely

influ

ence

the

heal

ing

proc

ess.

6.In

terv

entio

ns c

arrie

d ou

tin

a n

on-s

teril

een

viro

nmen

t.7.

Reg

ions

exp

osed

toin

appr

opria

te fo

rces

or

exce

ssiv

e w

eigh

t loa

ds.

8.Pa

tient

s unw

illin

g or

unab

le to

follo

win

stru

ctio

ns d

urin

g th

epo

stop

erat

ive

phas

e du

e to

thei

r men

tal,

neur

olog

ical

,or

phy

sica

l con

ditio

n.9.

Bon

e tu

mor

s loc

ated

in th

eim

plan

t bas

e re

gion

.10

.Obv

ious

dru

g or

alc

ohol

abus

e.11

.Sig

nific

ant c

hang

es to

the

patie

nt's

anat

omy

has

occu

rred

sinc

e th

e m

edic

alsc

an u

sed

for p

lann

ing

purp

oses

was

obt

aine

d.

1.O

bvio

us in

fect

ions

.2.

Hyp

erse

nsiti

vity

to fo

reig

nbo

dies

.3.

Circ

ulat

ory

prob

lem

s,sy

stem

ic d

isea

ses,

and

met

abol

ic d

isor

ders

.4.

Insu

ffic

ient

or i

nade

quat

ebo

ne ti

ssue

.5.

Seco

ndar

y di

seas

es su

chas

deg

ener

ativ

e pr

oces

ses

that

may

neg

ativ

ely

influ

ence

the

heal

ing

proc

ess.

6.In

terv

entio

ns c

arrie

d ou

tin

a n

on-s

teril

een

viro

nmen

t (e.

g.pa

rana

sal s

inus

es).

7.R

egio

ns e

xpos

ed to

inap

prop

riate

forc

es o

rex

cess

ive

wei

ght l

oads

.8.

Patie

nts u

nwill

ing

orun

able

to fo

llow

inst

ruct

ions

dur

ing

the

post

oper

ativ

e ph

ase

due

toth

eir m

enta

l, ne

urol

ogic

al,

or p

hysi

cal c

ondi

tion.

9.B

one

tum

ors l

ocat

ed in

the

impl

ant b

ase

regi

on.

10.O

bvio

us d

rug

or a

lcoh

olab

use.

11.S

igni

fican

t cha

nges

toth

e pa

tient

's an

atom

y ha

soc

curr

ed si

nce

the

med

ical

scan

use

d fo

r pla

nnin

gpu

rpos

es w

as o

btai

ned.

1.O

bvio

us in

fect

ions

.2.

Hyp

erse

nsiti

vity

to fo

reig

nbo

dies

.3.

Circ

ulat

ory

prob

lem

s,sy

stem

ic d

isea

ses,

and

met

abol

ic d

isor

ders

.4.

Insu

ffic

ient

or i

nade

quat

ebo

ne ti

ssue

.5.

Seco

ndar

y di

seas

es su

chas

deg

ener

ativ

e pr

oces

ses

that

may

neg

ativ

ely

influ

ence

the

heal

ing

proc

ess.

6.In

terv

entio

ns c

arrie

d ou

tin

a n

on-s

teril

een

viro

nmen

t (e.

g.pa

rana

sal s

inus

es).

7.R

egio

ns e

xpos

ed to

inap

prop

riate

forc

es o

rex

cess

ive

wei

ght l

oads

.8.

Patie

nts u

nwill

ing

orun

able

to fo

llow

inst

ruct

ions

dur

ing

the

post

oper

ativ

e ph

ase

due

toth

eir m

enta

l, ne

urol

ogic

al,

or p

hysi

cal c

ondi

tion.

9.B

one

tum

ors l

ocat

ed in

the

impl

ant b

ase

regi

on.

10.O

bvio

us d

rug

or a

lcoh

olab

use.

11.S

igni

fican

t cha

nges

toth

e pa

tient

's an

atom

y ha

soc

curr

ed si

nce

the

med

ical

scan

use

d fo

r pla

nnin

gpu

rpos

es w

as o

btai

ned.

1.O

bvio

us in

fect

ions

.2.

Hyp

erse

nsiti

vity

to fo

reig

nbo

dies

.3.

Susp

ecte

d se

nsiti

vity

to th

eim

plan

t mat

eria

l.4.

Circ

ulat

ory

prob

lem

s,sy

stem

ic d

isea

ses a

ndm

etab

olic

dis

orde

rs.

5.In

suff

icie

nt o

r ina

dequ

ate

bone

tiss

ue.

6.Se

cond

ary

dise

ases

such

as

dege

nera

tive

proc

esse

s tha

tm

ay n

egat

ivel

y in

fluen

ceth

e he

alin

g pr

oces

s.7.

Inte

rven

tions

car

ried

out i

n a

non-

ster

ile e

nviro

nmen

t(e

.g. p

aran

asal

sinu

ses)

.8.

Reg

ions

exp

osed

toin

appr

opria

te fo

rces

or

exce

ssiv

e w

eigh

t lo a

ds.

9.Pa

tient

s unw

illin

g or

una

ble

to fo

llow

inst

ruct

ions

dur

ing

the

post

oper

ativ

e ph

ase

due

to th

eir m

enta

l, ne

urol

ogic

alor

phy

sica

l con

ditio

n.10

.Ost

eopo

rosi

s or

oste

omal

acia

or o

ther

stru

ctur

al b

one

dam

age

prev

entin

g th

e st

able

fixat

ion

of im

plan

tco

mpo

nent

s.11

.Bon

e tu

mor

s loc

ated

in th

eim

plan

t bas

e re

gion

.12

.Obv

ious

dru

g or

alc

ohol

abus

e.

1.A

ctiv

e In

fect

ion.

2.N

ot in

tend

ed fo

r scr

ewat

tach

men

t or f

ixat

ion

to th

e po

ster

ior

elem

ents

(ped

icle

s) o

fth

e ce

rvic

al o

r lum

bar

spin

e.3.

Patie

nt c

ondi

tions

incl

udin

g: b

lood

supp

lylim

itatio

ns, i

nsuf

ficie

ntqu

antit

y or

qua

lity

ofbo

ne o

r lat

ent

infe

ctio

ns.

4.Pa

tient

s with

men

tal o

rne

urol

ogic

con

ditio

nsw

ho a

re u

nwill

ing

orin

capa

ble

of fo

llow

ing

post

oper

ativ

e ca

rein

stru

ctio

ns.

5.Fo

reig

n bo

dyse

nsiti

vity

. Whe

rem

ater

ial s

ensi

tivity

issu

spec

ted,

test

ing

is to

be c

ompl

eted

prio

r to

impl

anta

tion.

Page 6 of 10

K192979

1120

1 Sa

int J

ohns

Indu

stria

l Pkw

y S

Jack

sonv

ille,

FL

3224

6 Ph

one:

904

-641

-774

6 8

00-6

25-1

557

Fax

: 904

-641

-737

8 w

ww

.kls

mar

tinno

rtham

eric

a.co

m

KL

S M

artin

IPS

Plan

ning

Sy

stem

(Sub

ject

Dev

ice)

KL

S M

artin

IPS

Plan

ning

Sy

stem

K

1827

89

(Pri

mar

y Pr

edic

ate)

KL

S M

artin

IPS

Plan

ning

Sy

stem

K

1812

41

(Ref

eren

ce D

evic

e)

KL

S M

artin

Indi

vidu

al

Patie

nt S

olut

ions

K

1635

79

(Ref

eren

ce D

evic

e)

KL

S M

artin

Tho

raci

c Pl

atin

g Sy

stem

K

1534

82

(Ref

eren

ce D

evic

e)

Cla

ssifi

catio

n 21

CFR

892

.205

0, C

lass

II

21

CFR

888

.303

0, C

lass

II

21 C

FR 8

72.4

120,

Cla

ss II

21

CFR

892

.205

0, C

lass

II

21 C

FR 8

72.4

120,

Cla

ss II

21

CFR

892

.205

0, C

lass

II

21 C

FR 8

72.4

760,

Cla

ss II

21

CFR

888

.303

0, C

lass

II

Prod

uct C

ode

LLZ,

PB

F D

ZJ, L

LZ

DZJ

, LLZ

JE

Y

HR

S

Mat

eria

l A

nato

mic

al M

odel

s:

Epox

y/R

esin

, Acr

ylic

C

uttin

g/M

arki

ng G

uide

s: P

A,

Ti-6

Al-4

V, C

P Ti

tani

um

Ana

tom

ical

Mod

els:

Ep

oxy/

Res

in, A

cryl

ic

Cut

ting/

Mar

king

Gui

des:

PA

, Ti

-6A

l-4V

, CP

Tita

nium

Sp

lints

: met

hacr

ylat

e

Ana

tom

ical

Mod

els:

Ep

oxy/

Res

in, A

cryl

ic

Cut

ting/

Mar

king

Gui

des:

PA

, Ti

-6A

l-4V

, CP

Tita

nium

Sp

lints

: met

hacr

ylat

e

Not

app

licab

le

CP

Tita

nium

or T

itani

um

Allo

y (T

i-6A

l-4V

)

Man

ufac

turi

ng

Met

hod

Epox

y/R

esin

, Acr

ylic

: 3D

(S

LA)

CP

Tita

nium

: Tra

ditio

nal

(Sub

tract

ive)

Ti

-6A

l-4V

: 3D

(Add

itive

; SL

M)

Poly

amid

e: 3

D (A

dditi

ve;

SLS)

Epox

y/R

esin

, Acr

ylic

: 3D

(S

LA)

CP

Tita

nium

: Tra

ditio

nal

(Sub

tract

ive)

Ti

-6A

l-4V

: 3D

(Add

itive

; SL

M)

Poly

amid

e: 3

D (A

dditi

ve;

SLS)

Epox

y/R

esin

, Acr

ylic

: 3D

(S

LA)

CP

Tita

nium

: Tra

ditio

nal

(Sub

tract

ive)

Ti

-6A

l-4V

: 3D

(Add

itive

; SL

M)

Poly

amid

e: 3

D (A

dditi

ve;

SLS)

Ana

tom

ical

Mod

els:

Ep

oxy/

Res

in, A

cryl

ic

Impl

ants

: CP

Tita

nium

&

Tita

nium

Allo

y (T

i-6A

l-4V

)

CP

Tita

nium

: Tra

ditio

nal

(Sub

tract

ive)

Ti

-6A

l-4V

: Tra

ditio

nal

(Sub

tract

ive)

Soft

war

e M

ater

ialis

e M

imic

s (K

0734

68)

Geo

mag

ic®

Fre

efor

m P

lus™

Mat

eria

lise

Mim

ics

(K07

3468

) G

eom

agic

® F

reef

orm

Plu

s™

IPS

Cas

eDes

igne

r (K

1616

34)

Mat

hWor

ks®

MA

TLA

B

Mat

eria

lise

Mim

ics

(K07

3468

) G

eom

agic

® F

reef

orm

Plu

s™

IPS

Cas

eDes

igne

r (K

1616

34)

Mat

hWor

ks®

MA

TLA

B

Mat

eria

lise

Mim

ics (

K07

3468

) G

eom

agic

® F

reef

orm

Plu

s™

Not

app

licab

le

Tar

get P

opul

atio

n C

hild

, Ado

lesc

ent,

& A

dult

Pedi

atric

& A

dult

Ado

lesc

ent &

Adu

lt N

ot a

pplic

able

N

ot a

pplic

able

Ster

iliza

tion

Non

-ste

rile

(ste

am)

Non

-ste

rile

(ste

am)

Non

-ste

rile

(ste

am)

Non

-ste

rile

(ste

am)

Ster

ile (G

amm

a) o

r Non

-st

erile

(ste

am)

Ana

tom

ical

Site

s Th

orac

ic

Man

dibu

lar a

nd

Max

illof

acia

l M

andi

bula

r and

M

axill

ofac

ial

Man

dibu

lar

Thor

acic

Page 7 of 10

K192979

1120

1 Sa

int J

ohns

Indu

stria

l Pkw

y S

Jack

sonv

ille,

FL

3224

6 Ph

one:

904

-641

-774

6 8

00-6

25-1

557

Fax

: 904

-641

-737

8 w

ww

.kls

mar

tinno

rtham

eric

a.co

m

KL

S M

artin

IPS

Plan

ning

Sy

stem

(Sub

ject

Dev

ice)

KL

S M

artin

IPS

Plan

ning

Sy

stem

K

1827

89

(Pri

mar

y Pr

edic

ate)

KL

S M

artin

IPS

Plan

ning

Sy

stem

K

1812

41

(Ref

eren

ce D

evic

e)

KL

S M

artin

Indi

vidu

al

Patie

nt S

olut

ions

K

1635

79

(Ref

eren

ce D

evic

e)

KL

S M

artin

Tho

raci

c Pl

atin

g Sy

stem

K

1534

82

(Ref

eren

ce D

evic

e)

Gui

de S

peci

ficat

ions

T

hick

ness

C

uttin

g/M

arki

ng G

uide

M

in: 1

.0 m

m

Max

: 20

mm

Cut

ting/

Mar

king

Gui

de

Min

: 1.0

mm

M

ax: 5

.0 m

m

Cut

ting/

Mar

king

Gui

de

Min

: 1.0

mm

M

ax: 5

.0 m

m

Not

app

licab

le

Not

app

licab

le

Wid

th

Cut

ting/

Mar

king

Gui

de

Min

: 7 m

m

Max

: 300

mm

Cut

ting/

Mar

king

Gui

de

Min

: 7 m

m

Max

: 200

mm

Cut

ting/

Mar

king

Gui

de

Min

: 7 m

m

Max

: 200

mm

N

ot a

pplic

able

N

ot a

pplic

able

Len

gth

Cut

ting/

Mar

king

Gui

de

Min

: 7 m

m

Max

: 300

mm

Cut

ting/

Mar

king

Gui

de

Min

: 15

mm

M

ax: 3

50 m

m

Cut

ting/

Mar

king

Gui

de

Min

: 15

mm

M

ax: 3

50 m

m

Not

app

licab

le

Not

app

licab

le

Deg

ree

of

curv

atur

e (in

-pla

ne)

Cut

ting/

Mar

king

Gui

de

Min

: N/A

M

ax: N

/A

Cut

ting/

Mar

king

Gui

de

Min

: 90°

M

ax: 1

80°

Cut

ting/

Mar

king

Gui

de

Min

: 90°

M

ax: 1

80°

Not

app

licab

le

Not

app

licab

le

Deg

ree

of

curv

atur

e (o

ut-o

f-pl

ane)

Cut

ting/

Mar

king

Gui

de

Min

: N/A

M

ax: N

/A

Cut

ting/

Mar

king

Gui

de

Min

: 60°

M

ax: 1

80°

Cut

ting/

Mar

king

Gui

de

Min

: 60°

M

ax: 1

80°

Not

app

licab

le

Not

app

licab

le

Scre

w h

ole

spac

ing

Cut

ting/

Mar

king

Gui

de

Min

: ≥4.

5 m

m

Max

: No

Max

Cut

ting/

Mar

king

Gui

de

Min

: ≥4.

5 m

m

Max

: No

Max

Cut

ting/

Mar

king

Gui

de

Min

: ≥4.

5 m

m

Max

: No

Max

N

ot a

pplic

able

N

ot a

pplic

able

No.

of h

oles

C

uttin

g/M

arki

ng G

uide

M

in: N

/A

Max

: N/A

Cut

ting/

Mar

king

Gui

de

Min

: 2

Max

: Dep

ends

on

leng

th a

nd

hole

spac

ing

Cut

ting/

Mar

king

Gui

de

Min

: 2

Max

: Dep

ends

on

leng

th a

nd

hole

spac

ing

Not

app

licab

le

Not

app

licab

le

Scre

w Sp

ecifi

catio

ns

Dia

met

er

Tem

pora

ry: 2

.3 m

m -

3.2

mm

Te

mpo

rary

: 1.

5 m

m -

2.7

mm

Te

mpo

rary

: 1.5

mm

– 2

.7

mm

Pe

rman

ent:

2.0

mm

– 3

.2 m

m

Perm

anen

t: 2.

3 m

m -

3.2

mm

L

engt

h Te

mpo

rary

: 7 m

m -

17 m

m

Tem

pora

ry: 4

mm

– 2

2 m

m

Tem

pora

ry: 4

mm

– 2

2 m

m

Perm

anen

t: 5

mm

– 2

2 m

m

Perm

anen

t: 7

mm

- 17

mm

Styl

e m

axD

rive

(Dril

l-Fre

e,

non-

lock

ing,

lock

ing)

m

axD

rive

& c

ross

Driv

e (D

rill-F

ree,

non

-lock

ing,

lo

ckin

g, T

LTS)

max

Driv

e &

cro

ssD

rive

(Dril

l-Fre

e, lo

ckin

g, T

LTS)

m

axD

rive

& c

ross

Driv

e (D

rill-

Free

, loc

king

, TLT

S)

max

Driv

e (D

rill-F

ree,

lo

ckin

g)

Page 8 of 10

K192979

11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 Phone: 904-641-7746 800-625-1557 Fax: 904-641-7378 www.klsmartinnorthamerica.com

Non-Clinical Performance Data:

Performance Testing

Tensile and bending tests were performed to demonstrate that the subject devices made from polyamide can withstand multiple sterilization cycles without degradation and can maintain 85% of its initial tensile strength as outlined in the reference device, KLS Martin Individual Patient Solutions (IPS) Planning System (K181241). This testing also provides evidence of shelf life for the subject polyamide guides in that the material will not degrade or the performance of the device will not be affected within the shelf life period.

Tensile and bending tests for titanium were performed as outlined in the reference device, KLS Martin Individual Patient Solutions (K163579). Results of the testing demonstrate additively manufactured titanium devices are substantially equivalent to titanium devices manufactured using traditional (subtractive) methods. The subject titanium devices are identical in formulation, manufacturing processes, and post-processing procedures (cleaning & sterilization) as the reference device, K163579.

Biocompatibility Testing

Biocompatibility endpoints were evaluated in accordance with ISO 10993-1. The battery of cytotoxicity, sensitization, irritation, and chemical/material characterization testing conducted on the subject devices were within the pre-defined acceptance criteria, and therefore, adequately addresses biocompatibility for the output devices and their intended use.

Sterilization Testing

Steam sterilization validations were performed for each output device for the dynamic-air-removal cycle in accordance with ISO 17665-1:2006 to a sterility assurance level (SAL) of 10-6 using the biological indicator (BI) overkill method. All test method acceptance criteria were met.

Pyrogenicity Testing

LAL endotoxin testing was conducted according to AAMI ANSI ST72 on the subject devices to address the presence of bacterial endotoxins and ensure they meet pyrogen limit specifications. The results of the testing demonstrate that the KLS Martin IPS Planning System devices contain endotoxin levels below the USP allowed limit for medical devices and meet pyrogen limit specifications.

Software Verification and Validation

Software verification and validation was performed on each individual software application used in the planning and design of the output devices derived from the patient’s images (CT). Quality and on-site user acceptance testing provide objective evidence that all software requirements and specifications were implemented correctly and completely and are traceable to system requirements. Testing which was required as a result of risk analysis and impact assessments, showed conformity with pre-defined specifications and acceptance criteria. Software documentation demonstrates all appropriate steps have been taken to ensure mitigation of any potential risks and performs as intended based on the user requirements and specifications.

Page 9 of 10

K192979

11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 Phone: 904-641-7746 800-625-1557 Fax: 904-641-7378 www.klsmartinnorthamerica.com

Clinical Performance Data Clinical testing was not necessary for the determination of substantial equivalence.

Conclusion The KLS Martin IPS Planning System has the same intended use and similar technological characteristics as the primary predicate device. Technological differences have been addressed by leveraging performance data from the primary predicate and reference devices in addition to validating simulated use (planning session). No new or different questions of safety or effectiveness were identified, which supports the conclusion that the subject device system is substantially equivalent to the predicate device.

Page 10 of 10

K192979