FDA 510(k) Applications for Medical Device Product Code "KWA"
(Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))

FDA 510(k) Number Applicant Device Name Decision Date
K852699 ADVANCED BIOSEARCH ASSN. FREEMAN ACETABULAR CUP 09/05/1985
K850773 ADVANCED BIOSEARCH ASSN. PM CEMENTLESS SCREW-IN ACETABULAR CUP 05/02/1985
K844943 ADVANCED BIOSEARCH ASSN. WEILL CEMENTLESS THREADED ACETABULAR CUP 03/18/1985
K885049 ALLO PRO CORP. RS-CUP ACETABULAR PROSTHESIS 01/13/1989
K871453 ALLO PRO CORP. ZWEYMUELLER-SL HIP PROSTHESIS STEM 07/13/1987
K851213 ALLO PRO CORP. ZWEYMULLER CUP 05/28/1985
K842466 AMERICAN ORTOMED CORP. TITANIUM MITTELMEIER TYPE ACETABULAR 01/30/1985
K842518 AMERICAN ORTOMED CORP. UNILOC-CEMENTLESS & SELF TAP ACETABULAR 01/30/1985
K063614 BIOMET MANUFACTURING CORP. ALTRA FX HIP SYSTEM 02/20/2007
K063002 BIOMET MANUFACTURING CORP. ALTRA PRESS-FIT HIP SYSTEM 10/31/2006
K100469 BIOMET MANUFACTURING CORP. ARCOS INTERLOCKING DISTAL STEMS 12/07/2010
K101475 BIOMET MANUFACTURING CORP. COMPRESS ANTI-ROTATION SPINDLES 06/18/2010
K062998 BIOMET MANUFACTURING CORP. COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) 01/19/2007
K070274 BIOMET MANUFACTURING CORP. ECHO BI-METRIC PRESS-FIT STEMS 04/03/2007
K062994 BIOMET MANUFACTURING CORP. LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS 03/09/2007
K061423 BIOMET MANUFACTURING CORP. M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS 07/27/2006
K062995 BIOMET MANUFACTURING CORP. M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT 10/31/2006
K073637 BIOMET MANUFACTURING CORP. PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS 03/20/2008
K052888 BIOMET MANUFACTURING CORP. POROUS TITANIUM ACETABULAR AUGMENTS 12/06/2005
K110400 BIOMET MANUFACTURING CORP. TAPERLOC COMPLETE MICROPLASTY STEM 09/30/2011
K103755 BIOMET MANUFACTURING CORP. TAPERLOC COMPLETE, SIZE 5 AND 6 01/21/2011
K113271 BIOMET MANUFACTURING, INC. METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS 05/18/2012
K050251 BIOMET, INC. BALANCE HIP SYSTEM 05/27/2005
K082446 BIOMET, INC. BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS 10/15/2008
K090757 BIOMET, INC. BIOMET MODULAR FEMORAL REVISION SYSTEM 09/25/2009
K043547 BIOMET, INC. COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM 08/05/2005
K002379 BIOMET, INC. M2A 28MM RINGLOC LINER 08/31/2000
K011110 BIOMET, INC. M2A ACETABULAR SYSTEM 07/02/2001
K042037 BIOMET, INC. M2A MAGNUM SYSTEM 10/01/2004
K993438 BIOMET, INC. METAL ON METAL ACETABULAR SYSTEM 05/18/2000
K050124 BIOMET, INC. POROUS COATED ACETABULAR COMPONENTS 10/04/2005
K093235 BIOMET, INC. RINGLOC + HYBRID ACETABULAR SYSTEM 04/30/2010
K101086 BIOMET, INC. TAPERLOC COMPLETE 09/03/2010
K033943 CENTERPULSE ORTHOPEDICS, INC. ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED 10/18/2004
K033634 CENTERPULSE ORTHOPEDICS, INC. EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED 09/15/2004
K102080 DEPUY (IRELAND) DEPUY RECLAIM REVISION HIP SYSTEM 11/23/2010
K042992 DEPUY ORTHOPAEDICS, INC. CORAIL AMT HIP PROSTHESIS 02/11/2005
K082585 DEPUY ORTHOPAEDICS, INC. DEPUY ASPHERE M-SPEC HEAD 12/04/2008
K073413 DEPUY ORTHOPAEDICS, INC. DEPUY ASR 300 ACETABULAR CUP SYSTEM 01/30/2008
K040627 DEPUY ORTHOPAEDICS, INC. DEPUY ASR MODULAR ACETABULAR CUP SYSTEM 08/05/2005
K070359 DEPUY ORTHOPAEDICS, INC. DEPUY ASR TAPER SLEEVE ADAPTER 03/06/2007
K080991 DEPUY ORTHOPAEDICS, INC. DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM 07/02/2008
K082239 DEPUY ORTHOPAEDICS, INC. DEPUY C-STEM AMT 08/29/2008
K070554 DEPUY ORTHOPAEDICS, INC. DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS 09/11/2007
K090998 DEPUY ORTHOPAEDICS, INC. DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS 06/12/2009
K023786 DEPUY ORTHOPAEDICS, INC. DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER 12/10/2002
K062426 DEPUY ORTHOPAEDICS, INC. DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS 12/15/2006
K083642 DEPUY ORTHOPAEDICS, INC. DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS 03/06/2009
K003523 DEPUY ORTHOPAEDICS, INC. DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS 12/13/2000
K093646 DEPUY ORTHOPAEDICS, INC. DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS 12/17/2009
K073570 DEPUY ORTHOPAEDICS, INC. DEPUY TRI-LOCK BONE PRESERVATION STEM 02/21/2008
K061221 DEPUY ORTHOPAEDICS, INC. DUPUY S-ROM STD HIP STEM PROSTHESIS 08/28/2006
K002883 DEPUY ORTHOPAEDICS, INC. PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS 10/13/2000
K001523 DEPUY ORTHOPAEDICS, INC. ULTIMA METAL-ON-METAL ACETABULAR CUP 08/10/2000
K850055 DEPUY, INC. PROFILE FEMORAL HIP 04/23/1985
K871956 DOWNS SURGICAL LTD. MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT 06/23/1987
K864515 DOWNS SURGICAL LTD. RING UPM TOTAL HIP REPLACEMENT 03/13/1987
K052320 ENCORE MEDICAL CORPORATION ENCORE CLP OFFSET TOTAL HIP SYSTEM 12/30/2005
K092331 ENCORE MEDICAL, L.P. DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; 03/03/2010
K070221 ENCORE MEDICAL, L.P. FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 04/04/2007
K040354 ENCORE MEDICAL, L.P. METAL/METAL HIP SYSTEM 11/04/2004
K063414 ENCORE MEDICAL, L.P. MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38 12/12/2006
K083651 ENCORE MEDICAL, L.P. REVELATION STEM, MODEL 427-21/42-080/180 03/13/2009
K003250 ENCORE ORTHOPEDICS, INC. FMP METAL/METAL ACETABULAR INSERT 01/25/2001
K780330 HOWMEDICA CORP. TOTAL HIP, LORD MADREPORIC 05/12/1978
K924492 JOINT MEDICAL PRODUCTS CORP. POLY-DIAL INSERTS 11/24/1992
K851421 JOINT MEDICAL PRODUCTS CORP. S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP 06/04/1985
K882675 KINAMED, INC. ATH METAL:UHMWPE TOTAL HIP SYSTEM 08/19/1988
K852351 KIRSCHNER MEDICAL CORP. KIRSCHNER SELF-TAPPING ACETABULAR CUP 08/09/1985
K901626 MED-TEK CORP. H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED 08/14/1990
K922868 OSTEO TECHNOLOGY, INC. THOMPSON TYPE HIP PROTHESIS 02/12/1993
K861723 OSTEONICS CORP. (MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT 06/09/1986
K851404 OSTEONICS CORP. OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES 06/18/1985
K872768 OSTEONICS CORP. OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT. 01/14/1988
K850840 PFIZER, INC. HOWMEDICA THREADED ACETABULAR COMPONENT 07/15/1985
K870924 PROTEK, INC. CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT. 09/14/1987
K872985 PROTEK, INC. SAMUELSON ACETABULAR CUP 10/01/1987
K882671 PROTEK, INC. SAMUELSON SCREWLOC CUP 10/20/1988
K870923 PROTEK, INC. SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX. 09/14/1987
K993569 SULZER MEDICA APR METASUL ACETABULAR INSERT 12/01/1999
K003758 SULZER ORTHOPEDICS, INC. ALLOFIT ACETABULAR SYSTEM 03/07/2001
K974728 SULZER ORTHOPEDICS, INC. INTER-OP METASUL ACETABULAR SYSTEM 08/03/1999
K001536 SULZER ORTHOPEDICS, INC. INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS 07/27/2000
K895157 SYNERGY ORTHOPAEDICS INTL., INC. S.A.F. ACETABULAR CUP 12/01/1989
K902110 TURNKEY INTERGRATION USA, INC. MODIFIED FREEMAN ACETABULAR CUP 08/22/1990
K902111 TURNKEY INTERGRATION USA, INC. MODIFIED FREEMAN REVISION ACETABULAR CUP 08/22/1990
K843940 WALDEMAR LINK GMBH & CO. KG LINK CEMENTLESS SCREW-IN ACETABULAR CUP 06/03/1985
K843950 WALDEMAR LINK GMBH & CO. KG LINK CEMENTLESS SCREW-IN ACETABULAR CUP 06/03/1985
K102565 WRIGHT MEDICAL TECHNOLOGY, INC. ANTERIOR APPROACH HIP SURGERY INSTRUMENTS 12/22/2010
K110029 WRIGHT MEDICAL TECHNOLOGY, INC. CONSERVE BIO FOAM SHELL 04/19/2011
K042530 WRIGHT MEDICAL TECHNOLOGY, INC. CONSERVE PLUS HA ACETABULAR SHELLS 12/17/2004
K060356 WRIGHT MEDICAL TECHNOLOGY, INC. CONSERVE PLUS QUADRAFIX ACETABULAR SHELL 04/18/2006
K041425 WRIGHT MEDICAL TECHNOLOGY, INC. CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL 06/25/2004
K031963 WRIGHT MEDICAL TECHNOLOGY, INC. CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD 10/31/2003
K113322 WRIGHT MEDICAL TECHNOLOGY, INC. CONSERVE THIN SHELL 02/03/2012
K121544 WRIGHT MEDICAL TECHNOLOGY, INC. DYNASTY BIOFOAM SHELL 07/30/2012
K082924 WRIGHT MEDICAL TECHNOLOGY, INC. DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER 03/06/2009
K111910 WRIGHT MEDICAL TECHNOLOGY, INC. GLADIATOR HIP STEM 10/14/2011
K110399 WRIGHT MEDICAL TECHNOLOGY, INC. GLADIATOR PLASMA CLASSIC HIP STEM 05/10/2011
K043099 WRIGHT MEDICAL TECHNOLOGY, INC. LINEAGE HA ACETABULAR SHELLS 09/29/2005
K021349 WRIGHT MEDICAL TECHNOLOGY, INC. METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) 07/01/2002
K112080 WRIGHT MEDICAL TECHNOLOGY, INC. PRESERVE HIP STEM 12/28/2011
K043073 WRIGHT MEDICAL TECHNOLOGY, INC. PROCOTYL-E ACETABULAR SYSTEM 05/04/2005
K053588 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR LX HIP STEM 01/13/2006
K112150 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR GLADIATOR HA HIP STEM 11/23/2011
K091423 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR HIP SYSTEM MODULAR NECKS 08/25/2009
K081090 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR LX 5/8 COATED HIP STEM 05/15/2008
K080663 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR LX REVISION 5/8 COATED HIP STEM 04/08/2008
K060358 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR TL HIP STEM 05/10/2006
K113019 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER 11/10/2011
K052915 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR XTR HIP STEM 01/27/2006
K122778 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR Z REVISION HIP STEM 10/11/2012
K111698 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR(R) E CEMENTLESS HIP STEM 08/19/2011
K111699 WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM 08/19/2011
K110836 ZIMMER GMBH CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY 10/07/2011
K053536 ZIMMER GMBH DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS 03/16/2006
K091973 ZIMMER GMBH METASUL TAPER LINERS, METASUL FEMORAL HEADS 11/17/2009
K091003 ZIMMER GMBH ZIMMER MMC CUP 11/24/2009
K071723 ZIMMER GMBH ZIMMER POROLOCK MIS STEM 03/07/2008
K081007 ZIMMER, INC. ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM 05/06/2008
K071856 ZIMMER, INC. ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES 07/30/2007
K063251 ZIMMER, INC. ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY 01/24/2007
K850766 ZIMMER, INC. ZIMMER THREADED ACETABULAR CUP 05/01/1985


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact