# K223528: Triathlon® Hinge Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Jan 20, 2023 after 58 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- 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: 10 generations back to K943462 (1994). 92 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994207: Howmedica Osteonics Modular Rotating Hinge Knee, Howmedica Osteonics Corp. (2000) Summary page 4.
- K002552: Howmedica Osteonics Modular Rotating Hinge Knee, Howmedica Osteonics Corp. (2000) Summary page 4.
- K001548: Modular Rotating Hinge Knee Crossover Tibial Bearing Components, Howmedica Osteonics Corp. (2000) Summary page 4.
- K001957: Modular Rotating Hinge Knee Tibial Rotating Component, Howmedica Osteonics Corp. (2000) Summary page 4.
- K070095: Triathlon TS Knee System, Howmedica Osteonics Corp. (2007) Summary page 5.
- K141056: Triathlon Knee System Posterior Stabilized Components, Stryker Orthopaedics (2014) Summary page 5.
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, Stryker Orthopaedics (2017) Summary page 5.
- K072221: Modification to Triathlon TS Knee System, Howmedica Osteonics Corp. (2007) Summary page 5.
- K172634: Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components, Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (2017) Summary page 5.
- K053514: Triathlon Total Knee System, Stryker Orthopaedics (2006) Summary page 5.

## Most influential descendants
- K230416: Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (2023), 3 descendants of its own
- K251665: Triathlon® Hinge Knee System (2025), 2 descendants of its own
- K261898: Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System (2026), 0 descendants of its own
- K252898: Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper (2025), 0 descendants of its own

## Recalls of this device
- Jul 30, 2026 · Class II · Z-3198-2026: Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which m

## Indications for use
This Rotating Hinge Knee System is intended to be implanted with bone cement for the following condition(s): • There is destruction of the joint surfaces, with or without significant bone deformity. • The cruciate and/or collateral ligaments do not stabilize the knee joint. • The ligaments are inadequate and/or the musculature is weak. And/or • Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue. • And/or where segmental resection and replacement of the distal femur is required.

Source page: https://510kreport.com/device/K223528
Methodology: https://510kreport.com/methodology