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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 ([email protected]) 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) [email protected]
“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: [email protected]
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