# K253637: Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Decided: Feb 18, 2026 after 91 days
- Product code: MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K943462 (1994). 253 ancestors in all.
No later device cites it as a predicate yet.
0 of 254 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242831: Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System, Howmedica Osteonics Corp., Dba Stryker Orthopaedics (2024) Summary page 6.
- K243293: Zimmer® Persona® Personalized Knee System, Zimmer Biomet (2024) Summary page 6.

## Indications for use
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. * Ligamentous instability requiring implant bearing surface geometries with increased constraint. * Absent or non-functioning posterior cruciate ligament.

Source page: https://510kreport.com/device/K253637
Methodology: https://510kreport.com/methodology