KXA — Prosthesis, Hip, Femoral, Resurfacing Class II
FDA product code KXA covers "Prosthesis, Hip, Femoral, Resurfacing", a Class II medical device regulated under 21 CFR 888.3400. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KXA
- Device Class
- Class II
- Regulation Number
- 888.3400
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201219 | biocore9 | Biocore9 Femoral Head Resurfacing Component | January 19, 2021 |
| K092198 | corin usa | CORMET CEMENTLESS RESURFACING FEMORAL HEAD | April 15, 2010 |
| K082673 | wrightmedicaltechnologyinc | CONSERVE PRESSFIT FEMORAL COMPONENT | December 12, 2008 |
| K071053 | biomet | RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD | June 29, 2007 |
| K070292 | zimmer | DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS | April 26, 2007 |
| K062960 | wrightmedicaltechnologyinc | CONSERVE FEMORAL RESURFACING COMPONENT | December 1, 2006 |
| K043542 | biopro | BIOPRO TARA FEMORAL RESURFACING COMPONENT | May 18, 2005 |
| K032659 | depuy orthopaedics | DEPUY ASR RESURFACING FEMORAL HEADS | December 4, 2003 |
| K023188 | biomet orthopedics | PRESS-FIT HEAD RESURFACING DEVICE | December 11, 2002 |
| K021549 | std mfg | CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM | August 1, 2002 |
| K021799 | biomet orthopedics | CEMENTED FEMORAL HEAD RESURFING DEVICE | June 26, 2002 |
| K994153 | corin usa | CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS | February 25, 2000 |
| K983452 | biomet | NELSON RESURFACING HEAD | December 3, 1998 |
| K950998 | intermedics orthopedics | MODUILAR UNIPOLAR | April 13, 1995 |
| K944752 | orthomet | ORTHOMET RESURFACING FEMORAL COMPONENT | December 28, 1994 |
| K904870 | endotec | MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON | May 23, 1991 |
| K894604 | biopro | BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT | November 17, 1989 |
| K892398 | orthomet | BIPOLAR HIP SYSTEM | May 23, 1989 |
| K883212 | implant technology | LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT | November 22, 1988 |
| K842233 | endomedics | NEW JERSEY FEMORAL RESURFACING COMPONENT | July 20, 1984 |