510(k) K253793 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Materialise TKA Guide System
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Jan 6, 2026 |
| Received | Nov 28, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253793
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.