KXA · Prosthesis, Hip, Femoral, Resurfacing
Orthopedic · 21 CFR 888.3400 · Class 2
Overview
| Product Code | KXA |
|---|---|
| Device Name | Prosthesis, Hip, Femoral, Resurfacing |
| Regulation | 21 CFR 888.3400 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.
Classification Rationale
Class II.
Cleared Devices (23)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K201219 | Biocore9 Femoral Head Resurfacing Component | Biocore9, LLC | Jan 19, 2021 | SESE |
| K092198 | CORMET CEMENTLESS RESURFACING FEMORAL HEAD | Corin USA | Apr 15, 2010 | SESE |
| K082673 | CONSERVE PRESSFIT FEMORAL COMPONENT | Wrightmedicaltechnologyinc | Dec 12, 2008 | SESE |
| K071053 | RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD | Biomet, Inc. | Jun 29, 2007 | SESE |
| K070292 | DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS | Zimmer GmbH | Apr 26, 2007 | SESE |
| K062960 | CONSERVE FEMORAL RESURFACING COMPONENT | Wrightmedicaltechnologyinc | Dec 1, 2006 | SESE |
| K043542 | BIOPRO TARA FEMORAL RESURFACING COMPONENT | Biopro, Inc. | May 18, 2005 | SESE |
| K032659 | DEPUY ASR RESURFACING FEMORAL HEADS | DePuy Orthopaedics, Inc. | Dec 4, 2003 | SESE |
| K023188 | PRESS-FIT HEAD RESURFACING DEVICE | Biomet Orthopedics, Inc. | Dec 11, 2002 | SESE |
| K021549 | CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM | Std Mfg., Inc. | Aug 1, 2002 | SESE |
| K021799 | CEMENTED FEMORAL HEAD RESURFING DEVICE | Biomet Orthopedics, Inc. | Jun 26, 2002 | SESE |
| K994153 | CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS | Corin USA | Feb 25, 2000 | SESE |
| K983452 | NELSON RESURFACING HEAD | Biomet, Inc. | Dec 3, 1998 | SESE |
| K950998 | MODUILAR UNIPOLAR | Intermedics Orthopedics | Apr 13, 1995 | SESE |
| K944752 | ORTHOMET RESURFACING FEMORAL COMPONENT | Orthomet, Inc. | Dec 28, 1994 | SESE |
| K904870 | MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON | Endotec, Inc. | May 23, 1991 | SESE |
| K894604 | BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT | Biopro, Inc. | Nov 17, 1989 | SN |
| K892398 | BIPOLAR HIP SYSTEM | Orthomet, Inc. | May 23, 1989 | SESE |
| K883212 | LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT | Implant Technology, Inc. | Nov 22, 1988 | SESE |
| K842233 | NEW JERSEY FEMORAL RESURFACING COMPONENT | Endomedics, Inc. | Jul 20, 1984 | SESE |
| K792200 | TILLMAN HIP RESURFACING REPLACEMT PROS. | Waldemar Link GmbH & Co. KG | Dec 5, 1979 | SESE |
| K781490 | TILLMAN HIPSURFACE REPLACEMENT | Waldemar Link GmbH & Co. KG | Sep 20, 1978 | SESE |
| K761324 | RESURFACE PROSTHESES FOR HIP JOINT | Holco Instrument Corp. | Jan 5, 1977 | SESE |
Top Applicants
- Wrightmedicaltechnologyinc — 2 clearances
- Waldemar Link GmbH & Co. KG — 2 clearances
- Orthomet, Inc. — 2 clearances
- Corin USA — 2 clearances
- Biopro, Inc. — 2 clearances
