RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
FDA 510(k) clearance K071053 · decided 2007-06-29
Clearance details
- K-number
- K071053
- Device name
- RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-13
- Decision date
- 2007-06-29
- Days to decision
- 77 days
- Clearance type
- Special
- 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 |
| 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 |
| DEPUY ASR RESURFACING FEMORAL HEADS (K032659) | DePuy Orthopaedics, Inc. | 2003-12-04 |
| 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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009) | Biomet, Inc. | 2011-02-11 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S004) | Biomet, Inc. | 2009-04-17 |
| C2A TAPER ACETABULAR SYSTEM (P050009/S007) | Biomet, Inc. | 2009-03-13 |
| C2-A TAPER ACETABULAR SYSTEM (P050009/S005) | Biomet, Inc. | 2007-11-30 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S002) | Biomet, Inc. | 2006-06-16 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S001) | Biomet, Inc. | 2006-02-01 |
| C2 A-TAPER ACETABULAR SYSTEM (P050009) | Biomet, Inc. | 2005-12-16 |