510(k) K090757 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
BIOMET MODULAR FEMORAL REVISION SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 25, 2009 |
| Received | Mar 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090757
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM
Item Number: 11-301300 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM
Item Number: 11-301301 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM
Item Number: 11-301302 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM
Item Number: 11-301310 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM
Item Number: 11-301311 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM
Item Number: 11-301312 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM
Item Number: 11-301314 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM
Item Number:
11-301315 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM
Item Number: 11-301321 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 70 MM
Item Number: 11-301322 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM
Item Number:11-301325 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM
Item Number: 11-301331 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM
Item Number: 11-301333 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM
Item Number: 11-301335 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM
Item Number: 11-301342 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM
Item Number: 11-301343 Terminated |
KWA | None listed |
| Jun 2, 2021 | Biomet, Inc. Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM
Item Number: 11-301354 Terminated |
KWA | None listed |
| Jun 8, 2018 | Zimmer Biomet, Inc. ARCOS Modular Revision Hip System, item number 11-300814 orthopedic hip prosthesis femoral stem. Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.