510(k) K253159 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Prophecy Incompass Surgical Planning System
| Applicant | Wright Medical Technology, Inc. (Stryker), Memphis TN, US |
| Decision | Substantially Equivalent, Jun 16, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253159
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.