Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
FDA product code LZO · 509 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3353
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1985-03-05 – 2026-09-17
LZO
2011-06-29
LZO
2011-06-27
APEX ARC HIP STEM
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LZO
2011-05-03
CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS
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LZO
2011-04-11
TAPER OXINIUM FEMORAL HEAD
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LZO
2011-03-10
DEPUY CORAIL HIP SYSTEM, REVISION STEM
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LZO
2011-02-28
CORIN BIOLOX DELTA FEMORAL HEADS
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LZO
2011-02-11
VERSAFITCUP CC TRIO
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LZO
2011-02-03
MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT
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LZO
2011-01-05
MULTIFIT TOTAL HIP SYSTEM
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LZO
2010-12-20
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK
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LZO
2010-11-23
DEPUY RECLAIM REVISION HIP SYSTEM
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LZO
2010-11-10
EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS
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LZO
2010-11-08
NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20
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LZO
2010-07-30
ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS
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LZO
2010-06-22
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
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LZO
2010-05-18
CARDO MEDICAL CERAMIC HIP SYSTEM
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LZO
2010-05-05
BIOLOX DELTA CERAMIC FEMORAL HEADS
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LZO
2010-04-28
PROFEMUR HIP SYSTEM MODULAR NECKS
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LZO
2010-04-15
SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS
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LZO
2010-04-07
APEX ARC HIP STEM
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LZO
2010-04-05
MINIHIP STEM
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LZO
2010-02-04
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
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LZO
2010-02-04
CORIN METAFIX FEMORAL STEM
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LZO
2010-01-21
MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S
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LZO
2009-12-16
44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM
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LZO
2009-04-24
BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS
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LZO
2009-03-11
BIOLOX DELTA CERAMIC FEMORAL HEADS
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LZO
2009-03-06
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C
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LZO
2009-02-09
SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM
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LZO
2009-01-15
MODIFICATION TO: METHA HIP SYSTEM
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LZO
2009-01-15
BIOLOX DELTA OPTION CERAMIC HEADS
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LZO
2008-12-17
NOVATION 12/14 CEMENTED FEMORAL STEMS
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LZO
2008-11-25
BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE
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LZO
2008-11-20
BIOLOX DELTA CERAMIC FEMORAL HEAD
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LZO
2008-10-15
ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS
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LZO
2008-09-26
ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS
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LZO
2008-08-07
METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM
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LZO
2008-06-09
SL-PLUS STANDARD AND LATERAL HIP STEMS
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LZO
2008-03-13
BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
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LZO
2008-02-21
DEPUY TRI-LOCK BONE PRESERVATION STEM
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LZO
2008-02-13
MECTACER BIOLOX FORTE-FEMORAL HEADS
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LZO
2008-02-06
DYNASTY CERAMIC FEMORAL HEAD
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LZO
2007-11-27
BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS
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LZO
2007-11-19
BIOLOX DELTA CERAMIC FEMORAL HEAD
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LZO
2007-09-28
DEPUY DELTA TS CERAMIC FEMORAL HEADS
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LZO
2007-09-13
STRYKER MODULAR HIP SYSTEM
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LZO
2007-09-11
DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS
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LZO
2007-08-01
CERAMIC BALL HEADS, 28, 32 AND 36 MM
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LZO
2007-05-16
UNIVERSAL TAPER DELTA FEMORAL HEAD
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LZO
2007-03-15
EXACTECH NOVATION CROWN CUP AND LINERS
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LZO
2007-02-02
PCA ALUMINA FEMORAL HEADS
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LZO
2006-12-20
TRIDENT II ACETABULAR SYSTEM
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LZO
2006-12-08
ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
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LZO
2006-11-30
MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
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LZO
2006-11-29
NOVATION SPLINED RDD FEMORAL STEMS
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LZO
2006-11-22
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
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LZO
2006-09-01
PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEAD
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LZO
2006-07-14
SYNERGY HIP SYSTEM
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LZO
2006-07-12
PATIENT MATCHED HIP STEM
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LZO
2006-06-06
36MM BIOLOX DELTA CERAMIC HEADS
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LZO
2006-05-26
EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
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LZO
2006-05-10
HIPSTAR FEMORAL STEM
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LZO
2006-04-28
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
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LZO
2006-03-17
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS
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LZO
2006-02-06
MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
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LZO
2005-12-27
ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5)
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LZO
2005-12-07
SMITH & NEPHEW PLATFORM HIP STEM
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LZO
2005-12-01
ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM
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LZO
2005-11-18
EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS
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LZO
2005-10-27
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
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LZO
2005-09-27
ACCOLADE RPS HIP STEM
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LZO
2005-09-26
ACCOLADE HFX FEMORAL STEM
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LZO
2005-09-06
SC CERAMIC BALL HEADS
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LZO
2005-07-19
SECUR-FIT MAX AND PLUS MAX HIP STEMS
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LZO
2005-07-19
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
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LZO
2005-07-19
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
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LZO
2005-07-12
BIOLOX DELTA CERAMIC FEMORAL HEADS
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LZO
2005-06-29
ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS
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LZO
2005-05-11
ALUMINA HEAD
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LZO
2005-04-18
WAGNER SL REVISION STEM LATERAL
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LZO
2005-03-25
BIOLOX DELTA CERAMIC HEADS
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LZO
2005-02-11
CORAIL AMT HIP PROSTHESIS
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LZO
2005-02-11
HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS
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LZO
2004-11-17
ALUMINA HEAD
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LZO
2004-11-16
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM
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LZO
2004-11-09
NOVATION 12/14 PRESS-FIT FEMORAL STEM
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LZO
2004-11-09
SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS
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LZO
2004-09-15
CLS SPOTORNO STEM
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LZO
2004-08-25
MODIFICATION TO RESTORATION MODULAR SYSTEM
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LZO
2004-04-29
MS-30 FEMORAL STEM STANDARD AND LATERAL
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LZO
2004-04-08
MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
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LZO
2004-03-12
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
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LZO
2003-12-17
MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM
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LZO
2003-10-24
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
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LZO
2003-09-22
WAGNER CONE PROSTHESIS
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LZO
2003-07-01
DEPUY CERAMIC FEMORAL HEADS
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LZO
2003-06-03
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
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LZO
2003-05-23
GMRS PRESS FIT STEMS WITH PUREFIX HA
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LZO
2003-04-10
CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM
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LZO
2003-03-06
ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM
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