DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
FDA 510(k) clearance K070292 · decided 2007-04-26
Clearance details
- K-number
- K070292
- Device name
- DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
- Applicant
- Zimmer GmbH
- Decision
- Substantially Equivalent
- Date received
- 2007-01-31
- Decision date
- 2007-04-26
- Days to decision
- 85 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 |
| 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
| Record | Firm | Date |
|---|---|---|
| Metasul Durom Femoral component Sterile, Rx recall (Z-0216-2013) | Zimmer, Inc. | 2012-11-06 |
| Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T; Catalog No.: 01.00211.1 recall (Z-0275-2008) | Zimmer Inc. | 2007-11-29 |
| Zimmer Durom Hip Resurfacing Systems, Femoral Component 46 Code L; Catalog No.: 01.00211.1 recall (Z-0276-2008) | Zimmer Inc. | 2007-11-29 |