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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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