510(k) K241875 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
TheRay Collared and Collarless Femoral Stem
| Applicant | Nextstep Arthropedix, Akron OH, US |
| Decision | Substantially Equivalent, Sep 13, 2024 |
| Received | Jun 28, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241875
| 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.