DEPUY ASR RESURFACING FEMORAL HEADS
FDA 510(k) clearance K032659 · decided 2003-12-04
Clearance details
- K-number
- K032659
- Device name
- DEPUY ASR RESURFACING FEMORAL HEADS
- Applicant
- DePuy Orthopaedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-28
- Decision date
- 2003-12-04
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- KXA
- Device class
- 2
- Regulation number
- 888.3400
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Biocore9 Femoral Head Resurfacing Component (K201219) | Biocore9, LLC | 2021-01-19 |
| CORMET CEMENTLESS RESURFACING FEMORAL HEAD (K092198) | Corin USA | 2010-04-15 |
| CONSERVE PRESSFIT FEMORAL COMPONENT (K082673) | Wrightmedicaltechnologyinc | 2008-12-12 |
| RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD (K071053) | Biomet, Inc. | 2007-06-29 |
| DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS (K070292) | Zimmer GmbH | 2007-04-26 |
| CONSERVE FEMORAL RESURFACING COMPONENT (K062960) | Wrightmedicaltechnologyinc | 2006-12-01 |
| BIOPRO TARA FEMORAL RESURFACING COMPONENT (K043542) | Biopro, Inc. | 2005-05-18 |
| PRESS-FIT HEAD RESURFACING DEVICE (K023188) | Biomet Orthopedics, Inc. | 2002-12-11 |
| CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM (K021549) | Std Mfg., Inc. | 2002-08-01 |
| CEMENTED FEMORAL HEAD RESURFING DEVICE (K021799) | Biomet Orthopedics, Inc. | 2002-06-26 |
| CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS (K994153) | Corin USA | 2000-02-25 |
| NELSON RESURFACING HEAD (K983452) | Biomet, Inc. | 1998-12-03 |
Recalls involving this device
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CERAMAX® Ceramic Total Hip System (P070026/S128) | DePuy Orthopaedics, Inc. | 2026-07-24 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S127) | DePuy Orthopaedics, Inc. | 2026-06-03 |
| Ceramax® Ceramic Hip System (P070026/S125) | DePuy Orthopaedics, Inc. | 2026-04-29 |
| Ceramax Ceramic Hip System (P070026/S124) | DePuy Orthopaedics, Inc. | 2026-04-10 |
| Ceramax® Ceramic Total Hip System (P070026/S118) | DePuy Orthopaedics, Inc. | 2026-01-08 |
| Ceramax Ceramic Hip System (P070026/S123) | DePuy Orthopaedics, Inc. | 2025-12-09 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S121) | DePuy Orthopaedics, Inc. | 2025-08-05 |
| CERAMAX CERAMIC HIP SYSTEM (P070026/S122) | DePuy Orthopaedics, Inc. | 2025-08-01 |