FDA 510(k) Applications for Medical Device Product Code "KWY"
(Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K080647 | ACCELERATED INNOVATION, LLC | ACCIN BIPOLAR HEAD SYSTEM | 07/08/2008 |
| K060707 | AESCULAP, INC. | AESCULAP BIPOLAR ACETABULAR CUP | 05/31/2006 |
| K080979 | BIOMET MANUFACTURING CORP. | STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT | 10/31/2008 |
| K960643 | BIOMET, INC. | ADVANTAGE MAPF HIP FEMORAL COMPONENT | 12/16/1996 |
| K003363 | BIOMET, INC. | M2A 32MM TAPER SYSTEM | 12/15/2000 |
| K052990 | BIOMET, INC. | STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM | 12/16/2005 |
| K991990 | BIOMET, INC. | TRI-POLAR SYSTEM | 09/10/1999 |
| K082705 | BIOPRO, INC. | BIOPRO BIPOLAR HEAD, MODELS 18130-18152 | 12/15/2008 |
| K100761 | BIOPRO, INC. | BIOPRO POLAR HEAD | 12/03/2010 |
| K040947 | CENTERPULSE ORTHOPEDICS, INC. | DURASUL BIPOLAR | 08/27/2004 |
| K112019 | CORENTEC CO., LTD | BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP | 10/12/2011 |
| K183114 | Corin USA Limited | Corin BiPolar-i | 06/05/2019 |
| K123991 | DEPUY FRANCE S.A.S. | DEPUY CORAIL AMT HIP PROSTHESIS | 09/16/2013 |
| K014072 | DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) | 03/08/2002 |
| K010081 | EXACTECH, INC. | ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS | 02/05/2001 |
| K013211 | EXACTECH, INC. | MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS | 12/05/2001 |
| K223441 | G21, S.r.l. | SpaceFlex Acetabular Cup | 03/23/2023 |
| K191016 | Heraeus Medical GmbH | COPAL exchange G Hip and Knee Spacers | 11/01/2019 |
| K220492 | Heraeus Medical GmbH | COPAL exchange G hip spacer | 03/23/2022 |
| K191569 | Implantcast, GmbH | Implantcast ic-Bipolar Head System | 08/28/2019 |
| K132539 | IMPLANTS INTERNATIONAL, LTD | RING-LOK MODULAR BIPOLAR SYSTEM | 02/07/2014 |
| K970447 | IMPLEX CORP. | IMPLEX BIPOLAR HIP SYSTEM | 04/30/1997 |
| K982812 | JOHNSON & JOHNSON PROFESSIONALS, INC. | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | 12/04/1998 |
| K980801 | JOHNSON & JOHNSON PROFESSIONALS, INC. | J-FX BIPOLAR HEAD | 05/29/1998 |
| K945518 | JOHNSON & JOHNSON PROFESSIONALS, INC. | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT | 03/08/1996 |
| K963885 | JOHNSON & JOHNSON PROFESSIONALS, INC. | ULTIMA FX FEMORAL HIP STEMS | 12/09/1996 |
| K200709 | Kyocera Medical Technologies, Inc. | Kyocera Bipolar Hip System | 04/17/2020 |
| K091967 | MEDACTA INTERNATIONAL, SA | MEDACTA BIPOLAR HEAD | 03/02/2010 |
| K082468 | OMNI LIFE SCIENCE, INC. | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) | 02/18/2009 |
| K100151 | OMNLIFE SCIENCE | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) | 05/28/2010 |
| K180130 | Onkos Surgical, Inc. | ELEOSÖ Bipolar Acetabular System | 02/23/2018 |
| K961793 | ORTHO DEVELOPMENT CORP. | BI-LOC BIPOLAR CUP | 07/26/1996 |
| K982389 | ORTHO DEVELOPMENT CORP. | ODC B2 BIPOLAR CUP | 10/07/1998 |
| K050966 | ORTHO DEVELOPMENT CORP. | PIVOT BIPOLAR FEMORAL HEAD | 07/07/2005 |
| K962448 | ORTHO DEVELOPMENT CORP. | PRIMALOC CEMENTED HIP SYSTEM | 09/19/1996 |
| K953977 | ORTHO DEVELOPMENT CORP. | PRIMALOC CEMENTLESS HIP SYSTEM | 01/26/1996 |
| K982447 | PLUS ORTHOPEDICS | PLUS BIPOLAR PROSTHESIS COCRMO | 11/25/1998 |
| K131354 | RENOVIS SURGICAL TECHNOLOGIES LLC | RENOVIS BIPOLAR HIP SYSTEM | 09/19/2013 |
| K163081 | SIGNATURE ORTHOPAEDICS PTY LTD. | 40-42mm BiPolar Head and 22mm Femoral Head | 01/29/2018 |
| K023743 | SMITH & NEPHEW, INC. | SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM | 01/23/2003 |
| K173455 | SurgTech, Inc., | SurgTech Bipolar Head System | 06/14/2018 |
| K121509 | TGM MEDICAL, INC. | TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT | 11/05/2012 |
| K191297 | Theken Companies, LLC | iNSitu Bipolar Hip System | 09/17/2019 |
| K143113 | Total Joint Orthopedics | Klassic BiPolar System | 01/28/2015 |
| K970284 | TURNKEY INTERGRATION USA, INC. | ARTOS, DIPLOS SYSTEM | 04/21/1997 |
| K050269 | UNITED ORTHOPEDIC CORP. | U1 HIP SYSTEM - BIPOLAR | 08/29/2005 |
| K101670 | UNITED ORTHOPEDIC CORP. | UNITED U2 BIPOLAR IMPLANT | 10/08/2010 |
| K152439 | UNITED ORTHOPEDIC CORPORATION | U2 Bipolar Implant and 22mm Femoral Head | 04/07/2016 |
| K221794 | Waldemar Link GmbH & Co. KG | Vario-Cup System | 07/20/2022 |
| K981238 | WHITESIDE BIOMECHANICS, INC. | BIPOLAR FEMORAL HEAD | 08/21/1998 |
| K062693 | WRIGHT MEDICAL TECHNOLOGY, INC. | GLADIATOR BIPOLAR SYSTEM | 09/29/2006 |
| K192236 | Zimmer GmbH | Fitmore Hip Stem | 11/05/2019 |
| K170072 | Zimmer GmbH | Fitmore« Hip Stem | 02/07/2017 |
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