510(k) K251975 ยท NJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
| Applicant | Ignite Orthomotion, Winona Lake IN, US |
| Decision | Substantially Equivalent, Sep 2, 2025 |
| Received | Jun 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251975
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.