C2 A-TAPER ACETABULAR SYSTEM
FDA premarket approval P050009 · decided 2005-12-16
Approval details
- PMA number
- P050009
- Trade name
- C2 A-TAPER ACETABULAR SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Biomet, Inc.
- Date received
- 2005-03-14
- Decision date
- 2005-12-16
- Days to decision
- 277 days
- Decision code
- APWD
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Warsaw, IN
- Statement
- APPROVAL FOR THE C2A-TAPER ACETABULAR SYSTEM. THE DEVICE IS INDICATED FOR USE IN PRIMARY TOTAL HIP ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH NON-INFLAMMATORY DEGENERATIVE JOINT DISEASE SUCH AS OSTEOARTHRITIS, AVASCULAR NECROSIS, CONGENITAL HIP DYSPLASIA, AND POST-TRAUMATIC ARTHRITIS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OSSTM Orthopedic Salvage System (K253434) | Biomet, Inc. | 2026-07-01 |
| Taperloc® Complete Hip Stem (K251270) | Biomet, Inc. | 2026-05-19 |
| Biomet Kirschner Wires (K-Wires) (K241014) | Biomet, Inc. | 2024-05-22 |
| StageOne™ Select Hip Cement Spacer Molds (K222760) | Biomet, Inc. | 2022-12-28 |
| StageOne™ Shoulder Cement Spacer Molds (K221968) | Biomet, Inc. | 2022-09-15 |
| StageOne Knee Cement Spacer Molds (K213287) | Biomet, Inc. | 2022-09-02 |
| Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (K212431) | Biomet, Inc. | 2022-02-07 |
| Comprehensive Humeral Fracture Positioning Sleeves (K212435) | Biomet, Inc. | 2021-12-10 |