# K203099: Triathlon PKR System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
- Decided: Oct 27, 2020 after 13 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K943462 (1994). 85 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180612: Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts, Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (2018) Summary page 6.
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, Stryker Orthopaedics (2017) Summary page 6.

## Most influential descendants
- K241260: ACTIFY™ Unicondylar Knee System (2024), 0 descendants of its own

## 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/K203099
Methodology: https://510kreport.com/methodology