510(k) K251453 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Arthrex iBalance Partial Knee System
| Applicant | Arthrex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Jul 1, 2025 |
| Received | May 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251453
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.