510(k) K252898 · KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper
| Applicant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Dec 15, 2025 |
| Received | Sep 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252898
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Howmedica Osteonics Corp. SCORPIO C-DOME PATELLA
73-2710
73-2910
SCORPIO U-DOME PATELLA
73-3110
73-3508
73-3708
73-3710
73-3910
Orthopaedic implant components manufactured from UHMWPE (polyethylene) Open, Classified |
NPJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.