510(k) K193429 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Aug 13, 2020 |
| Received | Dec 10, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193429
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2025 | Howmedica Osteonics Corp. 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442;
2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352; Open, Classified |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.