510(k) K223528 · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Triathlon® Hinge Knee System
| Applicant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Jan 20, 2023 |
| Received | Nov 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223528
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. TRIATHLON HINGE INSERT SIZE 4 11MM
5612-P-411
TRIATHLON HINGE INSERT SIZE 4 13MM
5612-P-413
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.