# K251665: Triathlon® Hinge Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Jul 25, 2025 after 56 days
- Product code: KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K943462 (1994). 97 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230416: Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®, Stryker (2023) Summary page 6.
- K053514: Triathlon Total Knee System, Stryker Orthopaedics (2006) Summary page 6.
- K141056: Triathlon Knee System Posterior Stabilized Components, Stryker Orthopaedics (2014) Summary page 6.
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, Stryker Orthopaedics (2017) Summary page 6.
- K023087: Global Modular Replacement System (GMRS), Howmedica Osteonics Corp. (2002) Summary page 6.
- K222056: Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2023) Summary page 6.
- K994207: Howmedica Osteonics Modular Rotating Hinge Knee, Howmedica Osteonics Corp. (2000) Summary page 6.
- K002552: Howmedica Osteonics Modular Rotating Hinge Knee, Howmedica Osteonics Corp. (2000) Summary page 6.

## Most influential descendants
- 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

## Indications for use
Triathlon® 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. When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis: • Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue. When used with compatible GMRS components: • Where segmental resection and/or replacement of femur and/or proximal tibia is required

Source page: https://510kreport.com/device/K251665
Methodology: https://510kreport.com/methodology