510(k) K253161 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Balanced Knee System TriMax Porous Femoral Components
| Applicant | Ortho Development Corp., Draper UT, US |
| Decision | Substantially Equivalent, Dec 19, 2025 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253161
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.