# K071881: Triathlon PKR System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp.
- Decided: Oct 9, 2007 after 92 days
- Product code: HRY (Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3530
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K040267 (2004). 16 ancestors in all.
25 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System, Howmedica Osteonics Corp. (2003) Summary page 1.
- K040267: Triathlon Cruciate Retaining (CR) Total Knee, Howmedica Osteonics Corp. (2004) Summary page 1.
- K051146: Triathlon Knee System, Howmedica Osteonics Corp. (2005)
- K063423: Triathlon CS (Condylar Stabilizing) Lipped Insert, Howmedica Osteonics (2007) Summary page 1.
- K992287: First Step Unicompartmental Knee System, Howmedica Osteonics Corp. (1999) Summary page 1.
- K033769: Eius Unicompartmental Knee System, Howmedica Osteonics Corp. (2004) Summary page 1.
- K896856: Mod-ML Unicompartmental Knee Prosthesis, Osteonics Corp. (1990) Summary page 1.
- K911373: Osteonics Ion Implant Mod-ML Uniknee Femoral Comp, Osteonics Corp. (1991) Summary page 1.
- K923011: Osteonics Unix Unicompartmental, Osteonics Corp. (1993)

## Most influential descendants
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own
- K173849: Triathlon Total Knee System (2018), 14 descendants of its own
- K190402: Triathlon Total Knee System-Additional Components (2019), 11 descendants of its own
- K230952: Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component (2023), 4 descendants of its own
- K223528: Triathlon® Hinge Knee System (2023), 4 descendants of its own

## Recalls of this device
- Nov 25, 2008 · Not classified · Z-0869-2009: Label mix-up: Stryker Orthopaedics became aware of a lot for lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 

## 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.

Source page: https://510kreport.com/device/K071881
Methodology: https://510kreport.com/methodology