510(k) K161592 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Persona Partial Knee System
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 3, 2016 |
| Received | Jun 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161592
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2017 | Zimmer Biomet, Inc. Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Mo Terminated |
HSX | None listed |
| Jul 5, 2017 | Zimmer Biomet, Inc. Persona Partial Knee System, Size 8, Finishing Guide Terminated |
HSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.