510(k) K253197 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
| Applicant | Depuy Ireland UC, Ringaskiddy, IE |
| Decision | Substantially Equivalent, Nov 19, 2025 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253197
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.