510(k) K143113 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Klassic BiPolar System
| Applicant | Total Joint Orthopedics, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jan 28, 2015 |
| Received | Oct 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143113
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2025 | Total Joint Orthopedics, Inc. Brand Name: Klassic BiPolar Head
Model/Catalog Number:
3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head;
3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head;
3205.43.022 Klassic BiPolar Hea Open, Classified |
KWY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.