510(k) K191297 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
iNSitu Bipolar Hip System
| Applicant | Theken Companies, LLC, Akron OH, US |
| Decision | Substantially Equivalent, Sep 17, 2019 |
| Received | May 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2025 | Theken Companies LLC iNSitu Bipolar Hip System, Bipolar head implant
Part ID Description
10-22-0038 Bipolar Head Assembly, Size 38mm
10-22-0040 Bipolar Head Assembly, Size 40mm
10-22-0042 Bipolar Head Assembly, Size 42mm Open, Classified |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.