# K230416: Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®

- Pathway: 510(k) (Traditional)
- Applicant: Stryker
- Decided: May 19, 2023 after 92 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: 11 generations back to K943462 (1994). 94 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002552: Howmedica Osteonics Modular Rotating Hinge Knee, Howmedica Osteonics Corp. (2000) Summary page 5.
- K994207: Howmedica Osteonics Modular Rotating Hinge Knee, Howmedica Osteonics Corp. (2000) Summary page 5.
- K223069: Modular Rotating Hinge Knee Systems and Compatible Components, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2023). Cleared while this submission was under review Summary page 5.
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, Stryker Orthopaedics (2017) Summary page 5.
- K141056: Triathlon Knee System Posterior Stabilized Components, Stryker Orthopaedics (2014) Summary page 5.
- K072221: Modification to Triathlon TS Knee System, Howmedica Osteonics Corp. (2007) Summary page 5.
- K070095: 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.
- K223528: Triathlon® Hinge Knee System, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2023) Summary page 5.

## Most influential descendants
- 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

## Indications for use
Triathlon® Hinge Knee System: 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. Triathlon® Revision Insert X3®: General Total Knee Arthroplasty (TKR) Indications: » Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. * Post-traumatic loss of knee joint configuration and function. » Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. * Revision of previous unsuccessful knee replacement or other procedure. * Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-management techniques. Additional Indications for Total Stabilizer (TS) Components: » Ligamentous instability requiring implant bearing surface geometries with increased constraint. * Absent or non-functioning posterior cruciate ligament. » Severe anteroposterior instability of the knee joint. » Severe instability of the knee secondary to compromised collateral ligament integrity or function.

Source page: https://510kreport.com/device/K230416
Methodology: https://510kreport.com/methodology