510(k) K122765 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
PERSONA NATURAL TIBIA BASEPLATES
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 9, 2012 |
| Received | Sep 10, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122765
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2017 | Zimmer Biomet, Inc. PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyart Terminated |
JHW | None listed |
| Aug 7, 2017 | Zimmer Biomet, Inc. Persona Cemented Tibial SZ PLT Size H Left, Item Number 42539908301
For use during orthopaedic surgery for implantation of a prosthesis. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.