A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Partial Knee Resurfacing (PKR) Unicondylar Knee System
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Sponsor: Stryker Orthopaedics



Triathlon® PKR Outcomes Study  
 
 
Stryker Orthopaedics Clinical Study Protocol  
 
 
Version 2.0   26-Sep-2019 
 
 
 
 
 
Triathlon PKR Femoral 
Component 
  Catalog no. 
Size (mm) 
5610-F-101 
#1 LM/RL 
5610-F-102 
#1 RM/LL 
5610-F-201 
#2 LM/RL 
5610-F-202 
#2 RM/LL 
5610-F-301 
#3 LM/RL 
5610-F-302 
#3 RM/LL 
5610-F-401 
#4 LM/RL 
5610-F-402 
#4 RM/LL 
5610-F-501 
#5 LM/RL 
5610-F-502 
#5 RM/LL 
5610-F-601 
#6 LM/RL 
5610-F-602 
#6 RM/LL 
 
                                                                                                
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Triathlon PRK Tibial 
Tray/Baseplate 
Catalog no. 
Size (mm) 
5620-B-101 
 #1 LM/RL 
5620-B-102 
 #1 RM/LL 
5620-B-201 
 #2 LM/RL 
5620-B-202 
 #2 RM/LL 
5620-B-301 
 #3 LM/RL 
5620-B-302 
#3 RM/LL 
5620-B-401 
 #4 LM/RL 
5620-B-402 
 #4 RM/LL 
5620-B-501 
 #5 LM/RL 
5620-B-502 
 #5 RM/LL 
5620-B-601 
 #6 LM/RL 
5620-B-602 
 #6 RM/LL 
Triathlon PKR Tibial Insert 
Catalog no. 
Size (mm) 
5630-G-408 
#4 LM/RL -8MM 
5630-G-409 
#4 LM/RL -9MM 
5630-G-410 
#4 LM/RL -10MM 
5630-G-412 
#4 LM/RL -12MM 
5630-G-420 
 #4 RM/LL -10MM 
5630-G-422 
#4 RM/LL -12MM 
5630-G-428 
#4 RM/LL -8MM 
5630-G-429 
#4 RM/LL -9MM 
5630-G-508 
#5 LM/RL -8MM 
5630-G-509 
#5 LM/RL -9MM 
5630-G-510 
#5 LM/RL -10MM 
5630-G-512 
#5 LM/RL -12MM 
5630-G-520 
#5 RM/LL -10MM 
5630-G-522 
#5 RM/LL -12MM 
5630-G-528 
#5 RM/LL -8MM 
5630-G-529 
#5 RM/LL -9MM 
5630-G-608 
#6 LM/RL -8MM 
5630-G-609 
#6 LM/RL -9MM 
5630-G-610 
#6 LM/RL -10MM 
5630-G-612 
#6 LM/RL -12MM 
5630-G-620 
#6 RM/LL -10MM 
5630-G-622 
#6 RM/LL -12MM 
5630-G-628 
#6 RM/LL -8MM 
5630-G-629 
#6 RM/LL -9MM 
 Triathlon PKR Tibial Insert 
Catalog no. 
Size (mm) 
5630-G-108 
#1 LM/RL -8MM 
5630-G-109 
#1 LM/RL -9MM 
5630-G-110 
#1 LM/RL -10MM 
5630-G-112 
#1 LM/RL -12MM 
5630-G-120 
#1 RM/LL -10MM 
5630-G-122 
#1 RM/LL -12MM 
5630-G-128 
#1 RM/LL -8MM 
5630-G-129 
#1 RM/LL -9MM 
5630-G-208 
#2 LM/RL -8MM 
5630-G-209 
#2 LM/RL -9MM 
5630-G-210 
#2 LM/RL -10MM 
5630-G-212 
#2 LM/RL -12MM 
5630-G-220 
#2 RM/LL -10MM 
5630-G-222 
#2 RM/LL -12MM 
5630-G-228 
#2 RM/LL -8MM 
5630-G-229 
#2 RM/LL -9MM 
5630-G-308 
#3 LM/RL -8MM 
5630-G-309 
#3 LM/RL -9MM 
5630-G-310 
#3 LM/RL -10MM 
5630-G-312 
#3 LM/RL -12MM 
5630-G-320 
#3 RM/LL -10MM 
5630-G-322 
#3 RM/LL -12MM 
5630-G-328 
#3 RM/LL -8MM 
5630-G-329 
#3 RM/LL -9MM 

L/07/fl'
OCT 
-940
510(k) Summary of Safety and Effectiveness
Triathlon* Knee System Line Extension
Submission Information
Name and Address of the Sponsor 
Howmedica Osteonics Corp
of the 510O(k) Submission: 
325 Corporate Drive
Mahwah, NJ 07430
For Information contact: 
Vivian Kelly, Sr. Regulatory Affairs Specialist
H-owmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-5581 Fax: (201) 831-6038
Date Summary Prepared: 
July 6, 2007
Device Identification
Proprietary Name: 
Triathlona PKR System
Common Name: 
Knee Prosthesis Components
Classification Name and Reference: 
Knee Joint, Femorotibial, Polymer/Metal, Semi-constrained,
Cemented Prosthesis, 21 CFR §888.3530
Proposed Regulatory Class: 
Class 11
Device Panel/Product Code: 
87 HRY, Prosthesis, Knee, Femorotibial, semi-constrained,
Cemented, Metal/Polymer
Description:
The Triathlon® PIKR System is a modular unicondylar knee prostheses consisting of sterile, single-use
components intended for replacement of the medial or lateral femoral condyle regions for either the
right or left knee.
Indications for Use:
* 
Moderately disabling joint disease of the knee resulting from painful osteo- or post
traumatic arthritis
* 
Revision of previous unsuccessful surgical procedures, either involving, or not
involving, previous use of a unicompartmental knee prosthesis
* 
As an alternative to tibial osteotomy in patients with unicompartmental osteoartljritis
* 
Where bone stock is of poor quality or inadequate for other reconstructive techniques as
indicated by deficiencies of the femoral condyle/tibial plateau.
These components are intended for implantation with bone cement.
Substantial Equivalence:
The device is substantially equivalent to its predicates for femorotibial arthroplasty in regards to
intended use, design, materials, and operational principles. The analyses demonstrate that the
components from these systems are compatible when used for femnorotibial replacement. Examples of
predicate knee systems, include the Triathlon® Knee System (K03 1729, K040267) and X3® UHMWPE
Tibial Inserts and: Patellar Components (KO5I1146 & K063423), the EIUS® Unicompartmental Knee
System (K992287 & K033769), the SCR® Unicompartmental Knee Prosthesis (K896856 & K91 1373)
and the UJNIXTM Unicompartmental Knee System (K92301 I.) Based upon the mechanical testing, the
Triathlon® PKR System is substantially equivalent for its intended use to other femorotibial
replacement knees currently on the market.
6

4....... 
% 
DEPARTMENT OF HEALTH & HUMAN SERVICES 
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
OCT - 9 2007
Howmedica Osteonics Corp.
% Ms. Vivian Kelly, RAC
Senior Regulatory Affairs Specialist
325 Corporate Drive
Mahwah, NJ 07430
Re: K071881
Trade/Device Name: Triathlon PKR System
Regulation Number: 21 CFR 888.3530
Regulation Name: Knee joint femorotibial metal/polymer
semi-constrained cemented prosthesis
Regulatory Class: Class II
Product Code: HRY
Dated: July 6, 2007
Received: July 9, 2007
Dear Ms. Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
may be subject to such additional controls. Existing major regulations affecting your device can
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must
comply with all the Act's requirements, including, but not limited to: registration and listing (21
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic

Page 2 - Ms. Vivian Kelly
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This
letter will allow you to begin marketing your device as described in your Section 510(k)
premarket notification. The FDA finding of substantial equivalence of your device to a legally
marketed predicate device results in a classification for your device and thus, permits your device
to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance
at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance,
please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket
Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events
(Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems
at (240) 276-3464. You may obtain other general information on your responsibilities under the
Act from the Division of Small Manufacturers, International and Consumer Assistance
at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ark N. Melkerson
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure

Indications for Use
510(k) Number (if known): 
K01 q<' 
?
Device Name: Triathlon® PKR System
Indications for Use:
* 
Moderately disabling joint disease of the knee resulting from painful osteo- or post
traumatic arthritis
* 
Revision of previous unsuccessful surgical procedures, either involving, or not
involving, previous use of a unicompartmental knee prosthesis
* 
As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
·
Where bone stock is of poor quality or inadequate for other reconstructive techniques as
indicated by deficiencies of the femoral condyle/tibial plateau.
These components are intended for implantation with bone cement.
Prescription Use 
X 
Over-The-Counter Use
(Part 21 CFR 801 Subpart D) 
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of 1
Division tnYelf 
Res torntive,
and Neurologliul DoyCts
510 (k Nwruer 
C-)~

QIN 4388, Ver. AB ECN Release Date: Apr 27, 2
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QIN 4388, Ver. AB ECN Release Date: Apr 27, 2
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QIN 4388, Ver. AB ECN Release Date: Apr 27, 2
Print Date: Aug 03, 2018 15:41:17 GMT

QIN 4388, Ver. AB ECN Release Date: Apr 27, 2
Print Date: Aug 03, 2018 15:41:17 GMT

QIN 4388, Ver. AB ECN Release Date: Apr 27, 2
Print Date: Aug 03, 2018 15:41:17 GMT

QIN 4388, Ver. AB ECN Release Date: Apr 27, 2
Print Date: Aug 03, 2018 15:41:17 GMT

QIN 4388, Ver. AB ECN Release Date: Apr 27, 2
Print Date: Aug 03, 2018 15:41:17 GMT

QIN 4388, Ver. AB ECN Release Date: Apr 27, 2
Print Date: Aug 03, 2018 15:41:17 GMT

QIN 4388, Ver. AB ECN Release Date: Apr 27, 2
Print Date: Aug 03, 2018 15:41:17 GMT