510(k) K173057 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Zimmer Knee Joint Replacement Prostheses MR Labeling
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 29, 2018 |
| Received | Sep 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173057
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2023 | Zimmer, Inc. NexGen Precoat Stemmed Tibial Plate Size 5 Terminated |
JWH | None listed |
| Oct 10, 2019 | Zimmer Biomet, Inc. Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100
00522000200
00522000300
00522000400
00522006304
00522006504
00522006600
00522006800
00522006900
00522007000
005 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.