KWY · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Orthopedic · 21 CFR 888.3390 · Class 2
Overview
| Product Code | KWY |
|---|---|
| Device Name | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Regulation | 21 CFR 888.3390 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.
Classification Rationale
Class II.
Cleared Devices (99)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253357 | b-ONE® Bipolar Head | B-One Ortho, Corp. | Apr 13, 2026 | SESE |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. | Aug 25, 2025 | SESE |
| K231526 | CORAIL Cemented Femoral Stem | Depuy Ireland UC | Dec 19, 2023 | SESE |
| K223441 | SpaceFlex Acetabular Cup | G21, S.R.L. | Mar 23, 2023 | SESE |
| K221794 | Vario-Cup System | Waldemar Link GmbH & Co. KG | Jul 20, 2022 | SESE |
| K220492 | COPAL exchange G hip spacer | Heraeus Medical GmbH | Mar 23, 2022 | SESE |
| K200709 | Kyocera Bipolar Hip System | Kyocera Medical Technologies, Inc. | Apr 17, 2020 | SESE |
| K192236 | Fitmore Hip Stem | Zimmer GmbH | Nov 5, 2019 | SESE |
| K191016 | COPAL exchange G Hip and Knee Spacers | Heraeus Medical GmbH | Nov 1, 2019 | SESE |
| K191297 | iNSitu Bipolar Hip System | Theken Companies, LLC | Sep 17, 2019 | SESE |
| K191569 | Implantcast ic-Bipolar Head System | Implantcast GmbH | Aug 28, 2019 | SESE |
| K183114 | Corin BiPolar-i | Corin U.S.A. Limited | Jun 5, 2019 | SESE |
| K173455 | SurgTech Bipolar Head System | Surgtech, Inc. | Jun 14, 2018 | SESE |
| K180130 | ELEOS Bipolar Acetabular System | Onkos Surgical, Inc. | Feb 23, 2018 | SESE |
| K163081 | 40-42mm BiPolar Head and 22mm Femoral Head | Signature Orthopaedics Pty, Ltd. | Jan 29, 2018 | SESE |
| K170072 | Fitmore® Hip Stem | Zimmer GmbH | Feb 7, 2017 | SESE |
| K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | Apr 7, 2016 | SESE |
| K143113 | Klassic BiPolar System | Total Joint Orthopedics | Jan 28, 2015 | SESE |
| K132539 | RING-LOK MODULAR BIPOLAR SYSTEM | Implants International, Ltd. | Feb 7, 2014 | SESE |
| K131354 | RENOVIS BIPOLAR HIP SYSTEM | Renovis Surgical Technologies, LLC | Sep 19, 2013 | SESE |
| K123991 | DEPUY CORAIL AMT HIP PROSTHESIS | Depuy France S.A.S. | Sep 16, 2013 | SESE |
| K121509 | TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT | Tgm Medical, Inc. | Nov 5, 2012 | SESE |
| K112019 | BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP | Corentec Co., Ltd. | Oct 12, 2011 | SESE |
| K100761 | BIOPRO POLAR HEAD | Biopro, Inc. | Dec 3, 2010 | SESE |
| K101670 | UNITED U2 BIPOLAR IMPLANT | United Orthopedic Corp. | Oct 8, 2010 | SESE |
| K100151 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) | Omnlife Science | May 28, 2010 | SESE |
| K091967 | MEDACTA BIPOLAR HEAD | Medacta International S.A. | Mar 2, 2010 | SESE |
| K082468 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) | Omni Life Science, Inc. | Feb 18, 2009 | SESE |
| K082705 | BIOPRO BIPOLAR HEAD, MODELS 18130-18152 | Biopro, Inc. | Dec 15, 2008 | SESE |
| K080979 | STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT | Biomet Manufacturing Corp | Oct 31, 2008 | SESE |
| K080647 | ACCIN BIPOLAR HEAD SYSTEM | Accelerated Innovation, LLC | Jul 8, 2008 | SESE |
| K062693 | GLADIATOR BIPOLAR SYSTEM | Wrightmedicaltechnologyinc | Sep 29, 2006 | SESE |
| K060707 | AESCULAP BIPOLAR ACETABULAR CUP | Aesculap, Inc. | May 31, 2006 | SESE |
| K052990 | STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM | Biomet, Inc. | Dec 16, 2005 | SESE |
| K050269 | U1 HIP SYSTEM - BIPOLAR | United Orthopedic Corp. | Aug 29, 2005 | SESE |
| K050966 | PIVOT BIPOLAR FEMORAL HEAD | Ortho Development Corp. | Jul 7, 2005 | SESE |
| K040947 | DURASUL BIPOLAR | Centerpulse Orthopedics, Inc. | Aug 27, 2004 | SESE |
| K023743 | SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM | Smith & Nephew, Inc. | Jan 23, 2003 | SESE |
| K014072 | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) | Disc-O-Tech Medical Technologies, Ltd. | Mar 8, 2002 | SESE |
| K013211 | MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS | Exactech, Inc. | Dec 5, 2001 | SESE |
| K010081 | ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS | Exactech, Inc. | Feb 5, 2001 | SESE |
| K003363 | M2A 32MM TAPER SYSTEM | Biomet, Inc. | Dec 15, 2000 | SESE |
| K991990 | TRI-POLAR SYSTEM | Biomet, Inc. | Sep 10, 1999 | SESE |
| K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | Johnson & Johnson Professionals, Inc. | Dec 4, 1998 | SESE |
| K982447 | PLUS BIPOLAR PROSTHESIS COCRMO | Plus Orthopedics | Nov 25, 1998 | SESE |
| K982389 | ODC B2 BIPOLAR CUP | Ortho Development Corp. | Oct 7, 1998 | SESE |
| K981238 | BIPOLAR FEMORAL HEAD | Whiteside Biomechanics, Inc. | Aug 21, 1998 | SESE |
| K980801 | J-FX BIPOLAR HEAD | Johnson & Johnson Professionals, Inc. | May 29, 1998 | SESE |
| K970447 | IMPLEX BIPOLAR HIP SYSTEM | Implex Corp. | Apr 30, 1997 | SESE |
| K970284 | ARTOS, DIPLOS SYSTEM | Turnkey Intergration USA, Inc. | Apr 21, 1997 | SESE |
| K960643 | ADVANTAGE MAPF HIP FEMORAL COMPONENT | Biomet, Inc. | Dec 16, 1996 | SESE |
| K963885 | ULTIMA FX FEMORAL HIP STEMS | Johnson & Johnson Professionals, Inc. | Dec 9, 1996 | SESE |
| K962448 | PRIMALOC CEMENTED HIP SYSTEM | Ortho Development Corp. | Sep 19, 1996 | SN |
| K961793 | BI-LOC BIPOLAR CUP | Ortho Development Corp. | Jul 26, 1996 | SESE |
| K945518 | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT | Johnson & Johnson Professionals, Inc. | Mar 8, 1996 | SESE |
| K953977 | PRIMALOC CEMENTLESS HIP SYSTEM | Ortho Development Corp. | Jan 26, 1996 | SESE |
| K940743 | UHMWPE COMPONENTS-CHANGE IN PACKAGING | Depuy, Inc. | Sep 18, 1995 | SESE |
| K953510 | HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS | Encore Orthopedics, Inc. | Aug 9, 1995 | SESE |
| K945793 | P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR | Johnson & Johnson Professionals, Inc. | Apr 10, 1995 | SESE |
| K941534 | MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM | 3M Health Care, Ltd. | Mar 6, 1995 | SESE |
| K944132 | P.F.C. TOTAL HIP SYSTEM | Johnson & Johnson Professionals, Inc. | Jan 6, 1995 | SESE |
| K934159 | IOI COCR UNIPOLAR PROSTHESIS | Intermedics Orthopedics | Jul 21, 1994 | SESE |
| K931655 | P.F.C. BIPOLAR HIP SYSTEM | Johnson & Johnson Orthopaedics, Inc. | Jun 9, 1994 | SESE |
| K925153 | IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM | Howmedica Corp. | Mar 1, 1994 | SESE |
| K926387 | TECHMEDICA STANDARD CEMENTED HIP SYSTEM | Techmedica, Inc. | Feb 1, 1994 | SESE |
| K925536 | HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM | Orthomet, Inc. | Jan 7, 1994 | SN |
| K925420 | TECHMEDICA STANDARD BIPOLAR SYSTEM | Techmedica, Inc. | Sep 28, 1993 | SESE |
| K925897 | CORIN BIPOLAR PROSTHESIS | Corin Orthopedic Products | Aug 9, 1993 | SESE |
| K922560 | CONSENSUS(TM) BIPOLAR SYSTEM | U.S. Medical Products, Inc. | Sep 11, 1992 | SESE |
| K913632 | BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM | Kirschner Medical Corp. | Nov 13, 1991 | SESE |
| K905370 | EXACTECH BIPOLAR HIP PROSTHESIS | Exactech, Inc. | Feb 27, 1991 | SESE |
| K904383 | ACUFIT TOTAL HIP | Acu Med, Inc. | Dec 20, 1990 | SESE |
| K900051 | MOORE TYPE ENDO PROSTHESIS | Lima Intl. Corp. | Oct 3, 1990 | SESE |
| K896257 | LEINBACH HIP PROSTHESIS | 3M Company | Jan 19, 1990 | SESE |
| K895120 | BATEMAN UPF II HIP PROSTHESIS SYSTEM | 3M Company | Jan 11, 1990 | SESE |
| K896266 | VS22 HIP PROSTHESIS | 3M Company | Nov 22, 1989 | SESE |
| K893872 | P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT | Johnson & Johnson Professionals, Inc. | Sep 11, 1989 | SN |
| K893959 | P.S.A. FEMORAL HIP PROSTHESIS | Protek, Inc. | Jul 25, 1989 | SESE |
| K884658 | ZIMMER BEADED THREADED ACETABULAR CUP | Zimmer, Inc. | Nov 30, 1988 | SESE |
| K881289 | CORIN BIPOLAR PROSTHESIS | Orthopedic Systems, Inc. | Jun 29, 1988 | SESE |
| K873815 | IOI BIPOLAR PROSTHESIS | Intermedics Orthopedics | Oct 28, 1987 | SESE |
| K873514 | JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS | Johnson & Johnson Professionals, Inc. | Sep 24, 1987 | SESE |
| K872019 | BI-ARTICULAR II HIP DEVICE | Zimmer, Inc. | Jul 21, 1987 | SESE |
| K862460 | FEMORAL HEMI-HIP PROSTHESIS | Orthopaedic Device Corp. | Oct 6, 1986 | SESE |
| K862057 | KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD | Kirschner Medical Corp. | Jul 11, 1986 | SESE |
| K861566 | SLR BIPOLAR HIP ENDOPROSTHESIS | Dow Corning Wright | May 12, 1986 | SESE |
| K861105 | HOWMEDICA BIPOLAR PROSTHESIS | Howmedica Corp. | Apr 14, 1986 | SESE |
| K855231 | HOWMEDICA BIPOLAR PROSTHESIS | Howmedica Corp. | Feb 27, 1986 | SESE |
| K853795 | KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD | Kirschner Medical Corp. | Nov 22, 1985 | SESE |
| K842344 | HASTINGS BIPOLAR ENDOPROSTHESIS | Johnson & Johnson Professionals, Inc. | Sep 12, 1984 | SESE |
| K833404 | BDH BIPOLAR FEMORAL COMPONENT A3 | Carbomedics, Inc. | Mar 2, 1984 | SESE |
| K833991 | BIPOLAR HIP DEVICE | Zimmer | Jan 30, 1984 | SESE |
| K833175 | BIOMET BIPOLAR PROSTHESIS | Biomet, Inc. | Dec 22, 1983 | SESE |
| K823726 | SPECTRON CONVERSION ENDOPROSTHESIS CUP | Richard'S Medical Equip., Inc. | Mar 9, 1983 | SESE |
| K823482 | 101 UNIVERSAL ENDOPROSTHESIS | Intermedics Orthopedics | Feb 7, 1983 | SESE |
| K812672 | SELF-CENTERING HIP | Depuy, Inc. | Oct 8, 1981 | SESE |
| K810062 | BI-CENTRIC BI-POLAR ENDOPROSTHESIS | Howmedica Corp. | Jan 26, 1981 | SESE |
| K791823 | 3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM | 3M Company | Oct 30, 1979 | SESE |
| K781735 | ENDOPROSTHESIS SYSTEM, VARIO-HEAD | Waldemar Link GmbH & Co. KG | Oct 24, 1978 | SESE |
Top Applicants
- Johnson & Johnson Professionals, Inc. — 9 clearances
- Ortho Development Corp. — 5 clearances
- Biomet, Inc. — 5 clearances
- Howmedica Corp. — 4 clearances
- 3M Company — 4 clearances
