Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3400](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3400) → KXA — Prosthesis, Hip, Femoral, Resurfacing # KXA · Prosthesis, Hip, Femoral, Resurfacing _Orthopedic · 21 CFR 888.3400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA ## Overview - **Product Code:** KXA - **Device Name:** Prosthesis, Hip, Femoral, Resurfacing - **Regulation:** [21 CFR 888.3400](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3400) - **Device Class:** 2 - **Review Panel:** [Orthopedic](/submissions/OR) - **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. ## Recent Cleared Devices (20 of 23) Showing 20 most recent of 23 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K201219](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K201219.md) | Biocore9 Femoral Head Resurfacing Component | Biocore9, LLC | Jan 19, 2021 | SESE | | [K092198](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K092198.md) | CORMET CEMENTLESS RESURFACING FEMORAL HEAD | Corin USA | Apr 15, 2010 | SESE | | [K082673](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K082673.md) | CONSERVE PRESSFIT FEMORAL COMPONENT | Wrightmedicaltechnologyinc | Dec 12, 2008 | SESE | | [K071053](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K071053.md) | RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD | Biomet, Inc. | Jun 29, 2007 | SESE | | [K070292](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K070292.md) | DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS | Zimmer GmbH | Apr 26, 2007 | SESE | | [K062960](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K062960.md) | CONSERVE FEMORAL RESURFACING COMPONENT | Wrightmedicaltechnologyinc | Dec 1, 2006 | SESE | | [K043542](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K043542.md) | BIOPRO TARA FEMORAL RESURFACING COMPONENT | Biopro, Inc. | May 18, 2005 | SESE | | [K032659](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K032659.md) | DEPUY ASR RESURFACING FEMORAL HEADS | DePuy Orthopaedics, Inc. | Dec 4, 2003 | SESE | | [K023188](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K023188.md) | PRESS-FIT HEAD RESURFACING DEVICE | Biomet Orthopedics, Inc. | Dec 11, 2002 | SESE | | [K021549](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K021549.md) | CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM | Std Mfg., Inc. | Aug 1, 2002 | SESE | | [K021799](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K021799.md) | CEMENTED FEMORAL HEAD RESURFING DEVICE | Biomet Orthopedics, Inc. | Jun 26, 2002 | SESE | | [K994153](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K994153.md) | CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS | Corin USA | Feb 25, 2000 | SESE | | [K983452](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K983452.md) | NELSON RESURFACING HEAD | Biomet, Inc. | Dec 3, 1998 | SESE | | [K950998](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K950998.md) | MODUILAR UNIPOLAR | Intermedics Orthopedics | Apr 13, 1995 | SESE | | [K944752](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K944752.md) | ORTHOMET RESURFACING FEMORAL COMPONENT | Orthomet, Inc. | Dec 28, 1994 | SESE | | [K904870](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K904870.md) | MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON | Endotec, Inc. | May 23, 1991 | SESE | | [K894604](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K894604.md) | BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT | Biopro, Inc. | Nov 17, 1989 | SN | | [K892398](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K892398.md) | BIPOLAR HIP SYSTEM | Orthomet, Inc. | May 23, 1989 | SESE | | [K883212](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K883212.md) | LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT | Implant Technology, Inc. | Nov 22, 1988 | SESE | | [K842233](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA/K842233.md) | NEW JERSEY FEMORAL RESURFACING COMPONENT | Endomedics, Inc. | Jul 20, 1984 | SESE | ## Top Applicants - Biomet Orthopedics, Inc. — 2 clearances - Biomet, Inc. — 2 clearances - Biopro, Inc. — 2 clearances - Corin USA — 2 clearances - Orthomet, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KXA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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