FDA 510(k) Applications for Medical Device Product Code "LWJ"
(Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented)

FDA 510(k) Number Applicant Device Name Decision Date
K082146 AESCULAP IMPLANT SYSTEMS, INC. METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD 09/09/2008
K061699 AESCULAP, INC. EXCIA 08/18/2006
K042344 AESCULAP, INC. EXCIA TOTAL HIP SYSTEM 03/16/2005
K962268 ARTOS MEDICAL PRODUCTS GMBH CHROME COBALT BALL HEAD 10/23/1996
K962034 ARTOS MEDICAL PRODUCTS GMBH SC, CEMENTLESS HIP SYSTEM 10/23/1996
K120595 CONSENSUS ORTHOPEDICS, INC. UNISYN PLUS HIP STEM 10/12/2012
K010243 CORIN U.S.A. TRI-FIT FEMORAL STEM 02/15/2001
K103518 CORIN U.S.A. TRINITY ACETABULAR SYSTEM 03/09/2011
K030122 DEPUY ORTHOPAEDICS, INC. DEPUY SUMMIT BASIC PRESS-FIT HIP STEM 02/05/2003
K002941 ENCORE ORTHOPEDICS, INC. ACETABULAR PLATES 12/04/2000
K960633 ENCORE ORTHOPEDICS, INC. PRESS-FIT FLARED SHELL 10/01/1996
K964178 ENCORE ORTHOPEDICS, INC. PRESS-FIT HIP STEM 05/05/1997
K002141 EXACTECH, INC. ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT 08/16/2000
K090764 EXACTECH, INC. NOVATION CFS PRESS-FIT AND CEMENTED STEMS 04/21/2009
K070061 HAYES MEDICAL, INC. 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT 01/31/2007
K003649 HAYES MEDICAL, INC. TRITON HIP SYSTEM 02/23/2001
K062383 HAYES MEDICAL, INC. UNISYN HA PLASMA MODULAR HIP 12/21/2006
K972931 HHL CONSULTING PLUS EPF ACETABULAR CUP 11/13/1997
K023692 HOWMEDICA OSTEONICS CORP. GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER 03/20/2003
K993601 HOWMEDICA OSTEONICS CORP. HOWMEDICA OSTEONICS FEMORAL HEADS 11/16/1999
K022966 IMPLEX CORP. PROXILOCK HIP PROSTHESIS; SIZE 12/36 10/02/2002
K001471 IMPLEX CORP. THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ 08/07/2000
K954854 INTERMEDICS ORTHOPEDICS INTERMOORE FRACTURE HIP STEM 02/15/1996
K963155 INTERMEDICS ORTHOPEDICS INTERMOORE FRACTURE HIP STEM (MODIFY) 10/01/1996
K040685 OSTEOIMPLANT TECHNOLOGY, INC. Z - SERIES MODULAR TOTAL HIP SYSTEM PLASMA COATED 01/25/2005
K982936 OSTEONICS CORP. OSTEONICS EXTENDED FEMORAL BEARING HEAD 10/21/1998
K994146 PLUS ORTHOPEDICS EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP 12/11/2000
K030971 PLUS ORTHOPEDICS MODIFICATION TO MODULAR PLUS REVISION STEM 04/24/2003
K032709 PLUS ORTHOPEDICS MODULAR PLUS HIP STEM 09/23/2003
K994126 PLUS ORTHOPEDICS MODULAR-PLUS REVISION STEM 05/04/2000
K973077 PLUS ORTHOPEDICS PLUS-FIT ACETABULAR CUP 11/13/1997
K001942 PLUS ORTHOPEDICS SL-PLUS AND SLR-PLUS STEMS 07/25/2000
K024134 PLUS ORTHOPEDICS UNI HIP STEM 01/15/2003
K971900 PRO-LFIC LLC. LATERAL FLARE INTERNAL COLLAR (LFIC) 12/18/1997
K953268 STELKAST COMPANY DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT 01/17/1996
K001745 STELKAST COMPANY MODIFICATION TO PROVIDENT HIP SYSTEM 07/27/2000
K002796 STELKAST COMPANY MODIFICATION TO PROVIDENT HIP SYSTEM 09/28/2000
K032110 STELKAST COMPANY PROCLASS PRESS FIT HIP STEM 09/22/2003
K960908 STELKAST COMPANY SRRS PRESSED FIT FEMORAL REVISION COMPONENT 08/08/1996
K002575 SULZER ORTHOPEDICS, INC. INTER-OP DURASUL ACETABULAR INSERTS (4MM) 11/15/2000
K050262 UNITED ORTHOPEDIC CORP. U2 ACETABULAR COMPONENT 08/15/2005
K062978 UNITED ORTHOPEDIC CORP. U2 HIP STEM, TI PLASMA SPRAY 01/16/2007
K051826 WALDEMAR LINK GMBH & CO. KG BETACONE HIP PROSTHESIS SYSTEM 11/18/2005
K033313 WHITESIDE BIOMECHANICS, INC. QUATRO M FEMORAL COMPONENT 07/28/2004
K955553 WRIGHT MEDICAL TECHNOLOGY, INC. PERFECTA REVISION HIP SYSTEM 10/24/1996
K003016 WRIGHT MEDICAL TECHNOLOGY, INC. PRO-FEMUR R 12/13/2000
K961378 ZIMMER, INC. DELTA HIP PROSTHESIS 10/08/1996
K952776 ZIMMER, INC. LFIC OR FETTO HIP 02/14/1996


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