510(k) K253728 · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
EVOLUTION® AM BIOFOAM® Tibial System
| Applicant | Microport Orthopedics, Inc., Arlington TN, US |
| Decision | Substantially Equivalent, Aug 21, 2026 |
| Received | Nov 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253728
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.