Product code KXA
- Device name
- Prosthesis, Hip, Femoral, Resurfacing
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3400
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K201219 | Biocore9 Femoral Head Resurfacing Component | Biocore9, LLC | 2021-01-19 |
| K092198 | CORMET CEMENTLESS RESURFACING FEMORAL HEAD | Corin USA | 2010-04-15 |
| K082673 | CONSERVE PRESSFIT FEMORAL COMPONENT | Wrightmedicaltechnologyinc | 2008-12-12 |
| K071053 | RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD | Biomet, Inc. | 2007-06-29 |
| K070292 | DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS | Zimmer GmbH | 2007-04-26 |
| K062960 | CONSERVE FEMORAL RESURFACING COMPONENT | Wrightmedicaltechnologyinc | 2006-12-01 |
| K043542 | BIOPRO TARA FEMORAL RESURFACING COMPONENT | Biopro, Inc. | 2005-05-18 |
| K032659 | DEPUY ASR RESURFACING FEMORAL HEADS | DePuy Orthopaedics, Inc. | 2003-12-04 |
| K023188 | PRESS-FIT HEAD RESURFACING DEVICE | Biomet Orthopedics, Inc. | 2002-12-11 |
| K021549 | CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM | Std Mfg., Inc. | 2002-08-01 |
| K021799 | CEMENTED FEMORAL HEAD RESURFING DEVICE | Biomet Orthopedics, Inc. | 2002-06-26 |
| K994153 | CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS | Corin USA | 2000-02-25 |
| K983452 | NELSON RESURFACING HEAD | Biomet, Inc. | 1998-12-03 |
| K950998 | MODUILAR UNIPOLAR | Intermedics Orthopedics | 1995-04-13 |
| K944752 | ORTHOMET RESURFACING FEMORAL COMPONENT | Orthomet, Inc. | 1994-12-28 |
| K904870 | MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON | Endotec, Inc. | 1991-05-23 |
| K894604 | BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT | Biopro, Inc. | 1989-11-17 |
| K892398 | BIPOLAR HIP SYSTEM | Orthomet, Inc. | 1989-05-23 |
| K883212 | LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT | Implant Technology, Inc. | 1988-11-22 |
| K842233 | NEW JERSEY FEMORAL RESURFACING COMPONENT | Endomedics, Inc. | 1984-07-20 |
| K792200 | TILLMAN HIP RESURFACING REPLACEMT PROS. | Waldemar Link GmbH & Co. KG | 1979-12-05 |
| K781490 | TILLMAN HIPSURFACE REPLACEMENT | Waldemar Link GmbH & Co. KG | 1978-09-20 |
| K761324 | RESURFACE PROSTHESES FOR HIP JOINT | Holco Instrument Corp. | 1977-01-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M68436912860001 | DURAMER® | Microport Orthopedics Inc. | 2015-10-22 |
| M68438HM10361 | CONSERVE® | Microport Orthopedics Inc. | 2015-10-22 |
| M684380310561 | CONSERVE® | Microport Orthopedics Inc. | 2015-10-22 |
| M684380310541 | CONSERVE® | Microport Orthopedics Inc. | 2015-10-22 |
| M684380310521 | CONSERVE® | Microport Orthopedics Inc. | 2015-10-22 |
| M684380310501 | CONSERVE® | Microport Orthopedics Inc. | 2015-10-22 |
| M684380310481 | CONSERVE® | Microport Orthopedics Inc. | 2015-10-22 |
| M684380310461 | CONSERVE® | Microport Orthopedics Inc. | 2015-10-22 |
| M684380310441 | CONSERVE® | Microport Orthopedics Inc. | 2015-10-22 |
| M684380310421 | CONSERVE® | Microport Orthopedics Inc. | 2015-10-22 |
| M684380310401 | CONSERVE® | Microport Orthopedics Inc. | 2015-10-22 |
| M684380310381 | CONSERVE® | Microport Orthopedics Inc. | 2015-10-22 |
| M684380310361 | CONSERVE® | Microport Orthopedics Inc. | 2015-10-22 |
| M68436912864001 | DURAMER® | Microport Orthopedics Inc. | 2015-10-22 |
| M68436912862001 | DURAMER® | Microport Orthopedics Inc. | 2015-10-22 |
| M68436912858001 | DURAMER® | Microport Orthopedics Inc. | 2015-10-22 |
| M68436912856001 | DURAMER® | Microport Orthopedics Inc. | 2015-10-22 |
| M68436912854001 | DURAMER® | Microport Orthopedics Inc. | 2015-10-22 |
| M68436912852001 | DURAMER® | Microport Orthopedics Inc. | 2015-10-22 |
| M68436912850001 | DURAMER® | Microport Orthopedics Inc. | 2015-10-22 |
| M68436912848001 | DURAMER® | Microport Orthopedics Inc. | 2015-10-22 |
| M684201028561 | DURAMER® | Microport Orthopedics Inc. | 2015-10-22 |
| M528H1560032W0 | HemiCAP® | ARTHROSURFACE INCORPORATED | 2015-09-15 |
| M528H3520090W0 | HemiCAP® | ARTHROSURFACE INCORPORATED | 2015-09-15 |
| M528H3520085W0 | HemiCAP® | ARTHROSURFACE INCORPORATED | 2015-09-15 |
| M528H3520080W0 | HemiCAP® | ARTHROSURFACE INCORPORATED | 2015-09-15 |
| M528H3520075W0 | HemiCAP® | ARTHROSURFACE INCORPORATED | 2015-09-15 |
| M528H3520070W0 | HemiCAP® | ARTHROSURFACE INCORPORATED | 2015-09-15 |
| M528H3520065W0 | HemiCAP® | ARTHROSURFACE INCORPORATED | 2015-09-15 |
| M528H3520060W0 | HemiCAP® | ARTHROSURFACE INCORPORATED | 2015-09-15 |