510(k) K253328 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
GMK 3D Metal Tibial Tray Extension
| Applicant | Medacta International S.A., Castel San Pietro, CH |
| Decision | Substantially Equivalent, Feb 26, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253328
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.