Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
FDA product code KWA · 114 cleared devices
Class 3
Orthopedic
- Regulation
- 21 CFR 888.3330
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1978-05-12 – 2012-10-11
KWA
2012-10-11
KWA
2012-07-30
DYNASTY BIOFOAM SHELL
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KWA
2012-05-18
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
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KWA
2012-02-03
CONSERVE THIN SHELL
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KWA
2011-12-28
PRESERVE HIP STEM
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KWA
2011-11-23
PROFEMUR GLADIATOR HA HIP STEM
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KWA
2011-11-10
PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER
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KWA
2011-10-14
GLADIATOR HIP STEM
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KWA
2011-10-07
CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY
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KWA
2011-09-30
TAPERLOC COMPLETE MICROPLASTY STEM
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KWA
2011-08-19
PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM
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KWA
2011-08-19
PROFEMUR(R) E CEMENTLESS HIP STEM
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KWA
2011-05-10
GLADIATOR PLASMA CLASSIC HIP STEM
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KWA
2011-04-19
CONSERVE BIO FOAM SHELL
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KWA
2011-01-21
TAPERLOC COMPLETE, SIZE 5 AND 6
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KWA
2010-12-22
ANTERIOR APPROACH HIP SURGERY INSTRUMENTS
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KWA
2010-12-07
ARCOS INTERLOCKING DISTAL STEMS
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KWA
2010-09-03
TAPERLOC COMPLETE
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KWA
2010-06-18
COMPRESS ANTI-ROTATION SPINDLES
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KWA
2010-04-30
RINGLOC + HYBRID ACETABULAR SYSTEM
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KWA
2010-03-03
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110;
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KWA
2009-11-24
ZIMMER MMC CUP
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KWA
2009-11-17
METASUL TAPER LINERS, METASUL FEMORAL HEADS
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KWA
2009-09-25
BIOMET MODULAR FEMORAL REVISION SYSTEM
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KWA
2009-08-25
PROFEMUR HIP SYSTEM MODULAR NECKS
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KWA
2009-03-13
REVELATION STEM, MODEL 427-21/42-080/180
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KWA
2009-03-06
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
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KWA
2009-03-06
DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER
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KWA
2008-12-04
DEPUY ASPHERE M-SPEC HEAD
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KWA
2008-10-15
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
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KWA
2008-07-02
DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM
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KWA
2008-05-15
PROFEMUR LX 5/8 COATED HIP STEM
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KWA
2008-05-06
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM
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KWA
2008-04-08
PROFEMUR LX REVISION 5/8 COATED HIP STEM
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KWA
2008-03-20
PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS
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KWA
2008-03-07
ZIMMER POROLOCK MIS STEM
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KWA
2008-01-30
DEPUY ASR 300 ACETABULAR CUP SYSTEM
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KWA
2007-07-30
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES
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KWA
2007-04-04
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
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KWA
2007-04-03
ECHO BI-METRIC PRESS-FIT STEMS
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KWA
2007-03-09
LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS
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KWA
2007-03-06
DEPUY ASR TAPER SLEEVE ADAPTER
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KWA
2007-02-20
ALTRA FX HIP SYSTEM
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KWA
2007-01-24
ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY
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KWA
2007-01-19
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)
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KWA
2006-12-15
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
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KWA
2006-12-12
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34, 499-38
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KWA
2006-10-31
ALTRA PRESS-FIT HIP SYSTEM
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KWA
2006-10-31
M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT
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KWA
2006-08-28
DUPUY S-ROM STD HIP STEM PROSTHESIS
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KWA
2006-07-27
M2A MAGNUM 12/14 TAPER INSERTS AND ONE-PIECE MODULAR HEADS
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KWA
2006-05-10
PROFEMUR TL HIP STEM
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KWA
2006-04-18
CONSERVE PLUS QUADRAFIX ACETABULAR SHELL
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KWA
2006-03-16
DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
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KWA
2006-01-27
PROFEMUR XTR HIP STEM
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KWA
2006-01-13
PROFEMUR LX HIP STEM
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KWA
2005-12-30
ENCORE CLP OFFSET TOTAL HIP SYSTEM
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KWA
2005-12-06
POROUS TITANIUM ACETABULAR AUGMENTS
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KWA
2005-10-04
POROUS COATED ACETABULAR COMPONENTS
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KWA
2005-09-29
LINEAGE HA ACETABULAR SHELLS
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KWA
2005-08-05
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM
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KWA
2005-08-05
DEPUY ASR MODULAR ACETABULAR CUP SYSTEM
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KWA
2005-05-27
BALANCE HIP SYSTEM
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KWA
2005-05-04
PROCOTYL-E ACETABULAR SYSTEM
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KWA
2004-12-17
CONSERVE PLUS HA ACETABULAR SHELLS
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KWA
2004-11-04
METAL/METAL HIP SYSTEM
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KWA
2004-10-18
ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED
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KWA
2004-10-01
M2A MAGNUM SYSTEM
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KWA
2004-09-15
EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED
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KWA
2004-06-25
CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL
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KWA
2003-10-31
CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD
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KWA
2002-12-10
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER
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KWA
2002-07-01
METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
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KWA
2001-07-02
M2A ACETABULAR SYSTEM
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KWA
2001-03-07
ALLOFIT ACETABULAR SYSTEM
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KWA
2001-01-25
FMP METAL/METAL ACETABULAR INSERT
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KWA
2000-12-13
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
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KWA
2000-10-13
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
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KWA
2000-08-31
M2A 28MM RINGLOC LINER
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KWA
2000-08-10
ULTIMA METAL-ON-METAL ACETABULAR CUP
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KWA
2000-07-27
INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
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KWA
2000-05-18
METAL ON METAL ACETABULAR SYSTEM
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KWA
1999-12-01
APR METASUL ACETABULAR INSERT
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KWA
1999-08-03
INTER-OP METASUL ACETABULAR SYSTEM
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KWA
1993-02-12
THOMPSON TYPE HIP PROTHESIS
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KWA
1990-08-22
MODIFIED FREEMAN REVISION ACETABULAR CUP
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KWA
1990-08-22
MODIFIED FREEMAN ACETABULAR CUP
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KWA
1990-08-14
H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED
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KWA
1989-12-01
S.A.F. ACETABULAR CUP
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KWA
1989-01-13
RS-CUP ACETABULAR PROSTHESIS
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KWA
1988-10-20
SAMUELSON SCREWLOC CUP
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KWA
1988-08-19
ATH METAL:UHMWPE TOTAL HIP SYSTEM
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KWA
1988-01-14
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.
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KWA
1987-10-01
SAMUELSON ACETABULAR CUP
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KWA
1987-09-14
CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.
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KWA
1987-09-14
SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.
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KWA
1987-07-13
ZWEYMUELLER-SL HIP PROSTHESIS STEM
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KWA
1987-06-23
MODULAR RANGE OF RING PROS. FOR HIP REPLACEMENT
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KWA
1987-03-13
RING UPM TOTAL HIP REPLACEMENT
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KWA
1986-06-09
(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT
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