510(k) K090208 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
BIOPRO FEMORAL HEADS
| Applicant | Biopro, Inc., Port Huron MI, US |
| Decision | Substantially Equivalent, May 22, 2009 |
| Received | Jan 28, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090208
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2025 | BioPro, Inc. BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads
Part ID/Description:
18593 HEAD FEMORAL 22MM -3
18594 HEAD FEMORAL 22MM +0
19003 HEAD FEMORAL 28MM-6
19004 HEAD FEMORA Open, Classified |
LPH | None listed |
| Nov 4, 2011 | Biopro, Inc. BioPro Femoral Head 28 mm -6 mm, Item 19003.
Orthopedic femoral head for implantation. Terminated |
JDI | None listed |
| Nov 4, 2011 | Biopro, Inc. BioPro Femoral Head 28 mm +18, Item 19010.
Orthopedic femoral head for implantation Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.