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 |
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 |
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 |