510(k) K153437 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Apex Revision Knee System
| Applicant | Omnilife Science, East Taunton MA, US |
| Decision | Substantially Equivalent, Dec 21, 2015 |
| Received | Nov 27, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153437
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2025 | CORIN MEDICAL, LTD. Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-5255 Open, Classified |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.