KWL · Prosthesis, Hip, Hemi-, Femoral, Metal
Orthopedic · 21 CFR 888.3360 · Class 2
Overview
| Product Code | KWL |
|---|---|
| Device Name | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Regulation | 21 CFR 888.3360 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint femoral (hemi-hip) metallic cemented or uncemented 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 component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.
Classification Rationale
Class II.
Cleared Devices (106)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253675 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | Dec 23, 2025 | SESE |
| K252326 | InterSpace GV Hip Spacer | Tecres S.P.A. | Aug 6, 2025 | SESE |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | Biocomposites, Ltd. | Jun 12, 2025 | SESE |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+V | Heraeus Medical GmbH | Feb 15, 2024 | SESE |
| K222632 | UHR Bipolar Implants, Restoration GAP II Implants | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | Oct 21, 2022 | SESE |
| K192995 | OsteoRemedies Hip Spacer System | Osteoremedies, LLC | Jan 10, 2020 | SESE |
| K191981 | REMEDY Acetabular Cup | Osteoremedies, LLC | Aug 23, 2019 | SESE |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement | Osteoremedies, LLC | Aug 29, 2018 | SESE |
| K173967 | Remedy Acetabular Cup | Osteoremedies, LLC | Feb 22, 2018 | SESE |
| K143184 | Evolve UniPolar Head | Signature Orthopaedics Pty, Ltd. | Mar 17, 2015 | SESE |
| K112470 | 2GC HIP/KNEE MODULAR SPACER | Mandell Horwitz Consultants, LLC | Apr 5, 2012 | SESE |
| K101356 | Spacer-G and Spacer-K | Tecres S.P.A. | Sep 20, 2011 | SESE |
| K111911 | CORIN OPTIMOM MODULAR HEAD | Corin USA | Aug 4, 2011 | SESE |
| K062273 | SPACER-G TEMPORARY HIP PROSTHESIS | Tecres S.P.A. | May 22, 2008 | SESE |
| K071471 | CORIN ADAPTOR SLEEVE | Howmedica Osteonics Corp. | Sep 10, 2007 | SESE |
| K063791 | CORIN UNIPOLAR MODULAR HEAD | Corin USA | Apr 3, 2007 | SESE |
| K062408 | SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD | Smith & Nephew, Inc. | Sep 12, 2006 | SESE |
| K061243 | SMITH & NEPHEW MODULAR FEMORAL HEAD | Smith & Nephew, Inc. | Jul 17, 2006 | SESE |
| K042973 | SOLITUDE UNIPOLAR HEAD | Ortho Development Corp. | Jan 27, 2005 | SESE |
| K031841 | SPACER G TEMPORARY HIP PROSTHESIS | Exactech, Inc. | Jan 22, 2004 | SESE |
| K030972 | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH) | Disc-O-Tech Medical Technologies, Ltd. | May 30, 2003 | SESE |
| K030205 | CONSENSUS UNIPOLAR HEAD, COCR | Hayes Medical, Inc. | Apr 1, 2003 | SESE |
| K014226 | UNITRAX MODULAR UNIPOLAR SYSTEM | Howmedica Osteonics Corp. | Jan 25, 2002 | SESE |
| K992570 | UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE | Howmedica Osteonics Corp. | Sep 1, 1999 | SESE |
| K990309 | PLUS FRACTURE HEAD PROSTHESIS | Plus Orthopedics | Mar 15, 1999 | SESE |
| K984585 | OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE | Osteonics Corp. | Feb 24, 1999 | SESE |
| K984028 | THE NEW BIO-MOORE ENDO HEADS | Biomet, Inc. | Jan 19, 1999 | SESE |
| K981451 | ARGOMEDICAL BIPOLAR SYSTEM | Stelkast Company | Aug 21, 1998 | SESE |
| K974807 | OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM | Osteonics Corp. | Mar 16, 1998 | SESE |
| K973614 | FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES | Encore Orthopedics, Inc. | Dec 18, 1997 | SESE |
| K965198 | ULTIMA TPS CEMENTED STEM | Johnson & Johnson International | Jul 23, 1997 | SESE |
| K965156 | ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES | Johnson & Johnson Professionals, Inc. | Jan 24, 1997 | SESE |
| K962646 | PRIME MODULAR ENDO HEAD | Orthopaedic Innovations, Inc. | Sep 23, 1996 | SESE |
| K960538 | OPTEON UNIPOLAR | Exactech, Inc. | Mar 27, 1996 | SESE |
| K955385 | JOHNSON & JOHNSON AUSTIN MOORE STEM | Johnson & Johnson Professionals, Inc. | Jan 30, 1996 | SESE |
| K954534 | OSTEONICS UNIPOLAR ENDO HEAD | Osteonics Corp. | Nov 30, 1995 | SESE |
| K954077 | UNITRAX V40 MODULAR ADAPTOR | Howmedica Corp. | Nov 15, 1995 | SESE |
| K943778 | OSTEONICS RESTORATION CEMENTED HIP STEM SERIES | Osteonics Corp. | Aug 14, 1995 | SESE |
| K950563 | ULTIMA AUGMENTED UHMWPE CUP | Johnson & Johnson Professionals, Inc. | Jun 7, 1995 | SESE |
| K951355 | LINK SADDLE PROTHESIS | Turnkey Intergration USA, Inc. | May 25, 1995 | SESE |
| K931753 | CORIN THOMPSON PROSTHESIS, MODIFICATION | Corin Orthopedic Products | Oct 7, 1994 | SN |
| K931752 | CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION | Corin Orthopedic Products | Oct 7, 1994 | SESE |
| K940190 | ULTIMA UNIPOLAR MODULAR HEAD | Johnson & Johnson Orthopaedics, Inc. | Sep 29, 1994 | SESE |
| K934353 | ZIRCONIUM ALLOY UNI-POLAR HEAD | Smith & Nephew Richards, Inc. | Apr 25, 1994 | SESE |
| K924050 | TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT | Orthomet, Inc. | Aug 25, 1993 | SESE |
| K926120 | CONTOUR FEMORAL HIP STEM WITH POROCOAT | Depuy, Inc. | Mar 31, 1993 | SESE |
| K924379 | ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM | Johnson & Johnson Orthopaedics, Inc. | Feb 12, 1993 | SESE |
| K922146 | OSTRONCS HEMI-HIP STEM SERIES | Osteonics Corp. | Aug 11, 1992 | SESE |
| K920231 | OMNIFIT M-HA HIP STEM SERIES | Stryker Corp. | Jun 8, 1992 | SESE |
| K920193 | OMNIFLEX M-HA HIP STEM SERIES | Stryker Corp. | Jun 8, 1992 | SESE |
| K915868 | PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT | Orthomet, Inc. | Mar 23, 1992 | SESE |
| K903877 | MTS FEMORAL HIP SYSTEM | 3M Company | Jan 18, 1991 | SESE |
| K902365 | MODULAR UNIPOLAR SYSTEM | Howmedica Corp. | Jan 11, 1991 | SESE |
| K905349 | AUSTIN MOORE TYPE HIP PROTHESIS | O'Tec Corp. | Dec 11, 1990 | SESE |
| K905334 | THOMPSON TYPE HIP PROSTHESIS | O'Tec Corp. | Dec 11, 1990 | SESE |
| K904119 | PROFILE COLLARED HIP PROSTHESIS | Depuy, Inc. | Oct 11, 1990 | SN |
| K903885 | KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD | Kinamed, Inc. | Sep 13, 1990 | SESE |
| K903884 | KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD | Kinamed, Inc. | Sep 13, 1990 | SESE |
| K903241 | AUSTIN MOORE TYPE HIP PROSTHESIS | Onyx Medical Corp. | Jul 30, 1990 | SESE |
| K903240 | THOMPSON TYPE HIS PROSTHESIS | Onyx Medical Corp. | Jul 30, 1990 | SESE |
| K896853 | PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA | Howmedica Corp. | May 2, 1990 | SN |
| K900638 | P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT | Johnson & Johnson International | Apr 30, 1990 | SESE |
| K896105 | EVOLUTION HIP SYSTEM | Dow Corning Wright | Dec 29, 1989 | SN |
| K895886 | BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM | Biopro, Inc. | Dec 1, 1989 | SESE |
| K891482 | AML(R) COLLARLESS LATERALIZED FEMORAL HIP | Depuy, Inc. | May 16, 1989 | SN |
| K884889 | MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP. | Protek, Inc. | Feb 27, 1989 | SESE |
| K884789 | NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI | Protek, Inc. | Feb 8, 1989 | SN |
| K883179 | HIP FRACTURE STEM SYSTEM | Howmedica Corp. | Sep 22, 1988 | SESE |
| K874915 | ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS | Orthomet, Inc. | Feb 3, 1988 | SESE |
| K872535 | BIOPRO FEMORAL HIP COMPONENT | Biopro, Inc. | Aug 26, 1987 | SESE |
| K872776 | PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT | Depuy, Inc. | Aug 24, 1987 | SN |
| K872025 | POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS | Depuy, Inc. | Aug 18, 1987 | SN |
| K872878 | TRI-LOCK MODIFIED FEMORAL PROSTHESIS | Depuy, Inc. | Aug 7, 1987 | SN |
| K871656 | ORTHOMET AUSTIN-MOORE SYSTEM | Orthomet, Inc. | Jun 9, 1987 | SESE |
| K864085 | BROOKER BIO-GROOVE FEMORAL COMPONENT | Biomet, Inc. | Jan 28, 1987 | SESE |
| K854791 | BIO-FIT HIP SYSTEM | Richards Medical Co., Inc. | Feb 27, 1986 | SESE |
| K855228 | FEMORAL HEMI-HIP PROSTHESES | Orthopaedic Device Corp. | Feb 11, 1986 | SESE |
| K853662 | MUELLER CURVED STEM HEMI-PROSTHESIS | Protek, Inc. | Sep 24, 1985 | SESE |
| K852584 | POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT | Biomet, Inc. | Aug 15, 1985 | SESE |
| K844818 | NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS | Osteonics Corp. | Jul 30, 1985 | SESE |
| K852420 | BTM TOTAL HIP SYSTEM | Kirschner Medical Corp. | Jun 28, 1985 | SESE |
| K850928 | V.E.P. HIP -VARIABLE ENDO-PROSTHESIS | Unitas Ent. | May 28, 1985 | SESE |
| K843995 | TF-II HIP PROSTHESIS | Dow Corning Corp. Healthcare Industries Materials | Apr 23, 1985 | SESE |
| K845025 | AUSTIN-MOORE MODULAR HIP PROSTHESIS | Biomet, Inc. | Apr 19, 1985 | SESE |
| K844488 | MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS | Mecron Medical Products, Inc. | Mar 12, 1985 | SESE |
| K844487 | MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR | Mecron Medical Products, Inc. | Feb 19, 1985 | SESE |
| K844486 | MECRON MRC-HEADLESS FEMORAL COMPONENT | Mecron Medical Products, Inc. | Feb 19, 1985 | SESE |
| K842559 | WHITESIDE ORTHOLOC TOTAL HIP FEMORAL | Dow Corning Corp. Healthcare Industries Materials | Dec 20, 1984 | SESE |
| K842465 | UNILOC | American Ortomed Corp. | Nov 19, 1984 | SESE |
| K842234 | NEW JERSEY FEMORAL STEM | Endomedics, Inc. | Jul 20, 1984 | SESE |
| K841437 | PENNSYLVANIA HOSPITAL HIP SYS | Biomet, Inc. | Jun 25, 1984 | SESE |
| K833599 | MODIFIED HPS HIP PROSTHESIS | Depuy, Inc. | Mar 19, 1984 | SESE |
| K833403 | BDH UNIPOLAR FEMORAL COMPONENT A2 | Carbomedics, Inc. | Jan 10, 1984 | SESE |
| K831851 | STRAIGHT STEM FEMORAL HEAD PROSTHESIS | Proteck, Inc. | Oct 6, 1983 | SESE |
| K831420 | HIP PROSTHESIS -VARIOUS | The Oec Group | Sep 20, 1983 | SESE |
| K830307 | AUFRANC-TURNER ATS TOTAL HIP SYSTEM | Howmedica Corp. | Mar 10, 1983 | SESE |
| K823051 | METAL KNEE & HIP PROSTHESIS | Zimmer, Inc. | Dec 3, 1982 | SESE |
| K822321 | IOI 32 TM FEMORAL COMPONENT | Intermedics Orthopedics | Aug 20, 1982 | SESE |
| K822320 | KAMPNER FEMORAL COMPONENT | Intermedics Orthopedics | Aug 19, 1982 | SESE |
| K820755 | THE ORIGINAL LEINBACH PLATFORM TOTAL HIP | Allo Pro Corp. | Jun 10, 1982 | SESE |
| K821343 | BDH FEMORAL COMPONENT | Intermedics Orthopedics | Jun 3, 1982 | SESE |
| K811416 | MOORE HIP PROSTHESIS, PMMA COATED | Zimmer, Inc. | Aug 12, 1981 | SESE |
| K811738 | COLLARLESS TAPERED STEM HIP PROSTH. DEV | Biomet, Inc. | Jul 20, 1981 | SESE |
| K803191 | PROSTHESIS, HIP FEMORAL COMPONENT METAL | Osteonics Corp. | Jan 23, 1981 | SESE |
| K800207 | UHR UNIVERSAL6HIP REPLACEMENT | Osteonics Corp. | Feb 11, 1980 | SESE |
| K792181 | 3M HS 22 FEMORAL COMPONENT | 3M Company | Nov 15, 1979 | SESE |
Top Applicants
- Osteonics Corp. — 8 clearances
- Depuy, Inc. — 7 clearances
- Biomet, Inc. — 6 clearances
- Osteoremedies, LLC — 5 clearances
- Howmedica Corp. — 5 clearances
