510(k) K042271 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 13, 2004 |
| Received | Aug 23, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042271
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2025 | Zimmer, Inc. NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10 Open, Classified |
JWH | None listed |
| Dec 13, 2010 | Zimmer Inc. NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN. Terminated |
LXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.