FDA 510(k) Applications for Medical Device Product Code "LZO"
(Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)

FDA 510(k) Number Applicant Device Name Decision Date
K090299 AESCULAP IMPLANT SYSTEMS BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS 04/24/2009
K082991 AESCULAP IMPLANT SYSTEMS, INC. BIOLOX DELTA CERAMIC FEMORAL HEAD 11/20/2008
K081973 AESCULAP IMPLANT SYSTEMS, INC. METHA SHORT STEM HIP SYSTEM; MODULAR HIP SYSTEM; EXCIA HIP SYSTEM 08/07/2008
K083495 AESCULAP IMPLANT SYSTEMS, INC. MODIFICATION TO: METHA HIP SYSTEM 01/15/2009
K140915 AESCULAP IMPLANT SYSTEMS, LLC EXCIA TOTAL HIP SYSTEM 07/21/2014
K150062 AESCULAP IMPLANT SYSTEMS, LLC Excia Total Hip System 02/09/2015
K112682 AESCULAP IMPLANT SYSTEMS, LLC METHA HIP SYSTEM 03/19/2012
K172235 Aesculap Implants Systems, LLC CoreHip« System 03/28/2018
K060918 AESCULAP, INC. EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD 05/26/2006
K062684 AESCULAP, INC. EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD 11/22/2006
K012918 APEX SURGICAL, LLC. APEX MODULAR ALUMINA FEMORAL HEAD 11/27/2001
K003923 APEX SURGICAL, LLC. APEX MODULAR ZIRCONIA FEMORAL HEAD 03/20/2001
K111981 ASTON MEDICAL TREGOR DUAL MOBILITY ACETABULAR SYSTEM 10/12/2012
K173380 b-One Ortho Corp. b-ONE« Total Hip System 08/30/2018
K182705 b-ONE Ortho Corp. Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups 02/14/2019
K202768 b-One Ortho Corp. KOSMO Femoral Stem 04/01/2021
K954768 BIOLOGICALLY ORIENTED PROSTHESES BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD 01/18/1996
K992144 BIOLOGICALLY ORIENTED PROSTHESES BIOPRO RIMMED ACETABULAR COMPOMENT 09/22/1999
K093549 BIOMET MANUFACTURING CORP. 44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM 12/16/2009
K062997 BIOMET MANUFACTURING CORP. ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS 12/08/2006
K073102 BIOMET MANUFACTURING CORP. BIOLOX DELTA CERAMIC HEADS WITH 100KGY E-POLY ACETABULAR LINERS 11/27/2007
K200196 Biomet Orthopedics Taperloc« Complete Hip Stems 12/08/2020
K192683 Biomet UK Ltd. Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads 02/27/2020
K200959 Biomet UK Ltd. Biolox« delta Ceramic Heads, Biolox« delta Option Ceramic Heads MR Labeling 07/29/2020
K061312 BIOMET, INC. 36MM BIOLOX DELTA CERAMIC HEADS 06/06/2006
K051411 BIOMET, INC. ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS 06/29/2005
K955350 BIOMET, INC. BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM 02/16/1996
K042091 BIOMET, INC. BIOLOX DELTA CERAMIC HEADS 03/25/2005
K141653 BIOMET, INC. BIOLOX DELTA CERAMIC OPTION HEADS 08/18/2014
K082996 BIOMET, INC. BIOLOX DELTA OPTION CERAMIC HEADS 01/15/2009
K131684 BIOMET, INC. BIOLOX(R) DELTA CERAMIC HEADS 10/10/2013
K953925 BIOMET, INC. FINE GRAIN CAST COBALT CHROMIUM HIP STEMS 01/31/1996
K994184 BIOMET, INC. PLR SPLINED REVISION STEM 02/15/2000
K010560 BIOMET, INC. PORTRAIT FEMORAL COMPONENT 03/20/2001
K991708 BIOMET, INC. ZIRCONIA 22.22MM CERAMIC MODULAR HEADS 07/30/1999
K964431 BIOMET, INC. ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) 08/11/1997
K100008 CARDO MEDICAL, INC CARDO MEDICAL CERAMIC HIP SYSTEM 05/18/2010
K030373 CENTERPULSE ORTHOPEDICS, INC. ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM 03/06/2003
K032348 CENTERPULSE ORTHOPEDICS, INC. CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP 10/24/2003
K033664 CENTERPULSE ORTHOPEDICS, INC. MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM 12/17/2003
K032380 CENTERPULSE ORTHOPEDICS, INC. WAGNER CONE PROSTHESIS 09/22/2003
K121665 CORENTEC CO., LTD BENCOX FORET & BENCOX DELTA 09/25/2012
K223828 Corentec Co., Ltd. BENCOX Delta Option Heads 03/16/2023
K201657 Corin Ltd. Corin Ltd. Hip Products: TrinityÖ Acetabular System, TrinityÖ PLUS Acetabular Shell, MetaFixÖ Hip System, TriFitÖ CF and TS Hip Systems, TaperFitÖ Hip System, RevivalÖ Modular Hip System, MiniHipÖ, TrinityÖ Dual Mobility, MobiliT, BiPolar-i, OMNI MODÖ Hip 07/28/2021
K130128 CORIN MEDICAL TRINITY ACETABULAR SYSTEM 03/08/2013
K130634 CORIN U.S.A. CORIN METAFIX HIP STEM 05/24/2013
K130343 CORIN U.S.A. CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS 05/28/2013
K121439 CORIN U.S.A. METAFIX FEMORAL HIP STEM SIZE 1 09/14/2012
K120362 CORIN U.S.A. METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY 05/04/2012
K083312 CORIN U.S.A. MINIHIP STEM 04/05/2010
K992235 CORIN U.S.A. ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS 11/23/1999
K103120 CORIN USA CORIN BIOLOX DELTA FEMORAL HEADS 02/28/2011
K082525 CORIN USA CORIN METAFIX FEMORAL STEM 02/04/2010
K131952 CORIN USA CORIN METAFIX HIP STEM 12/16/2013
K111046 CORIN USA CORIN MINIHIP FEMORAL STEM 06/29/2011
K131986 CORIN USA CORIN MINIHIP STEM 12/16/2013
K190834 Corin USA Corin Optimized Position System Functional Hip Analysis (OPS FHA) 07/22/2019
K152893 CORIN USA Corin Optimized Positioning System (OPS) 06/03/2016
K193545 Corin USA Corin Optimized Positioning System (OPS) Femoral 08/04/2020
K181061 Corin USA Corin Optimized Positioning System (OPS) Femoral 09/07/2018
K110087 CORIN USA CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS 05/03/2011
K122305 CORIN USA CORIN TRINITY-I ACETABULAR SHELL 11/21/2012
K152903 CORIN USA REVIVAL(TM) Modular Revision Hip Stem 04/29/2016
K131647 CORIN USA TRINITY ACETABULAR SYSTEM 09/27/2013
K123705 CORIN USA TRINITY NON-OCCLUDED TITANIUM PLASMA SPRAYED (TPS) ACETABULAR SHELLS 02/12/2013
K153381 Corin USA Limited Corin Metafix Hip Stem 01/21/2016
K162942 CORIN USA LIMITED Corin MetaFix Hip Stem 06/20/2017
K212069 Corin USA Limited Corin MetaFixÖ Hip Stem 04/07/2022
K191831 Corin USA Limited MobiliT Cup 01/16/2020
K191374 Corin USA Limited Revival Modular Hip Stem 07/22/2019
K170359 Corin USA Limited TrinityÖ Dual Mobility System 10/31/2017
K190344 DePuy (Ireland) DePuy Corail AMT Hip Prosthesis 11/01/2019
K173960 DePuy France S.A.S. DePuy Corail AMT Hip Prosthesis 09/21/2018
K222296 Depuy Ireland UC ARTICUL/EZE Ceramic Heads 01/06/2023
K203532 Depuy Ireland UC BI-MENTUMÖ ALTRX« Dual Mobility Liner 04/28/2021
K221462 DePuy Ireland UC DePuy Reclaim Monobloc Revision Femoral Stem 10/21/2022
K211657 DePuy Ireland UC EMPHASYS Femoral Stems 08/05/2021
K123924 DEPUY ORTHOPAEDICS DEPUY GRIPTION TF 5.5MM STERILE LOCKING SCREWS 03/01/2013
K203167 DePuy Orthopaedics Inc. DePuy Corail AMT Hip Prosthesis 11/19/2020
K213839 DePuy Orthopaedics Inc. DePuy Corail AMT Hip Prosthesis 01/06/2022
K031803 DEPUY ORTHOPAEDICS, INC. DEPUY CERAMIC FEMORAL HEADS 07/01/2003
K192946 DePuy Orthopaedics, Inc. DePuy Corail AMT Hip Prosthesis 11/26/2019
K093736 DEPUY ORTHOPAEDICS, INC. DEPUY CORAIL HIP SYSTEM, REVISION STEM 03/10/2011
K071830 DEPUY ORTHOPAEDICS, INC. DEPUY DELTA TS CERAMIC FEMORAL HEADS 09/28/2007
K011533 DEPUY ORTHOPAEDICS, INC. DEPUY FEMORAL HEADS 01/28/2002
K002441 DEPUY ORTHOPAEDICS, INC. FENNING HIP STEM 09/01/2000
K040644 DEPUY ORTHOPAEDICS, INC. MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD 04/08/2004
K062748 DEPUY ORTHOPAEDICS, INC. MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD 11/30/2006
K000432 DEPUY ORTHOPAEDICS, INC. RESPONSE 2000 CEMENTED HIP STEM 04/24/2000
K000392 DEPUY ORTHOPAEDICS, INC. RESPONSE 2000 HIP STEM 04/24/2000
K170339 DePuy Orthopaedics, Inc. Summit Hip System 04/26/2018
K964704 DEPUY, INC. DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM 01/24/1997
K082844 ENCORE MEDICAL, L.P. BIOLOX DELTA CERAMIC FEMORAL HEAD, BIOLOX DELTA CERAMIC FEMORAL HEAD OFFSET SLEEVE 11/25/2008
K082398 ENCORE MEDICAL, L.P. ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS 10/15/2008
K991226 ENCORE ORTHOPEDICS, INC. FOUNDATION POROUS HIP STEM 06/01/1999
K980473 ENCORE ORTHOPEDICS, INC. PRESS-FIT STEM 04/16/1998
K965002 ENCORE ORTHOPEDICS, INC. ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS STEMS, THE ENCORE VITALITY STEMS AND SL AND 06/27/1997
K221323 Exactech, Inc Exactech« Alteon« Short Tapered Wedge 05/19/2023
K052787 EXACTECH, INC. ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) 12/27/2005
K051858 EXACTECH, INC. ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM 12/01/2005
K141821 EXACTECH, INC. ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET 08/28/2014
K051682 EXACTECH, INC. EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM 07/19/2005
K182462 Exactech, Inc. Exactech Alteon Highly Polished Femoral Stem 11/08/2018
K190890 Exactech, Inc. Exactech Alteon Modular Dual Mobility (MDM) System 10/22/2019
K150066 EXACTECH, INC. Exactech Alteon Monobloc Revision Stem 07/20/2015
K181532 Exactech, Inc. Exactech Alteon Monobloc Revision Stem 09/04/2018
K103012 EXACTECH, INC. EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS 11/10/2010
K070479 EXACTECH, INC. EXACTECH NOVATION CROWN CUP AND LINERS 03/15/2007
K140674 EXACTECH, INC. EXACTECH TAPERED WEDGE FEMORAL STEM 06/30/2014
K050398 EXACTECH, INC. EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS 11/18/2005
K060107 EXACTECH, INC. MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS 02/06/2006
K083392 EXACTECH, INC. NOVATION 12/14 CEMENTED FEMORAL STEMS 12/17/2008
K042842 EXACTECH, INC. NOVATION 12/14 PRESS-FIT FEMORAL STEM 11/09/2004
K121392 EXACTECH, INC. NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE 01/16/2013
K102487 EXACTECH, INC. NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 11/08/2010
K063279 EXACTECH, INC. NOVATION SPLINED RDD FEMORAL STEMS 11/29/2006
K042035 FOURNITURES HOSPITALIERES INDUSTRIE ALUMINA HEAD 11/17/2004
K050556 FOURNITURES HOSPITALIERES INDUSTRIE ALUMINA HEAD 05/11/2005
K123782 GLOBAL MANUFACTURING TECHNOLOGY PARAGON HIP SYSTEM 03/14/2013
K030151 HAYES MEDICAL, INC. CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM 04/10/2003
K964395 HAYES MEDICAL, INC. PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENT 01/27/1997
K981201 HOWMEDICA CORP. OSTEOLOCK ACETABULAR CUP 05/29/1998
K972893 HOWMEDICA CORP. PARTNERSHIP REVISION FEMORAL STEMS 11/03/1997
K970200 HOWMEDICA CORP. RELIANCE PF FEMORAL STEMS 04/09/1997
K983404 HOWMEDICA CORP. TYPE 3 FEMORAL COMPONENTS 12/22/1998
K031217 HOWMEDICA OSTEONICS GMRS PRESS FIT STEMS WITH PUREFIX HA 05/23/2003
K051588 HOWMEDICA OSTEONICS CORP BIOLOX DELTA CERAMIC FEMORAL HEADS 07/12/2005
K041940 HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS 02/11/2005
K051737 HOWMEDICA OSTEONICS CORP MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE 07/19/2005
K103233 HOWMEDICA OSTEONICS CORP MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT 02/03/2011
K051738 HOWMEDICA OSTEONICS CORP SECUR-FIT MAX AND PLUS MAX HIP STEMS 07/19/2005
K071082 HOWMEDICA OSTEONICS CORP STRYKER MODULAR HIP SYSTEM 09/13/2007
K063616 HOWMEDICA OSTEONICS CORP TRIDENT II ACETABULAR SYSTEM 12/20/2006
K070885 HOWMEDICA OSTEONICS CORP UNIVERSAL TAPER DELTA FEMORAL HEAD 05/16/2007
K052718 HOWMEDICA OSTEONICS CORP V40 BIOLOX DELTA CERAMIC FEMORAL HEADS 10/27/2005
K013106 HOWMEDICA OSTEONICS CORP. 2 PIECE MODULAR HIP STEM 04/03/2002
K002320 HOWMEDICA OSTEONICS CORP. ACCOLADE C FEMORAL COMPONENT 09/14/2000
K022555 HOWMEDICA OSTEONICS CORP. ACCOLADE C FEMORAL STEMS 08/26/2002
K023901 HOWMEDICA OSTEONICS CORP. ALUMINA V40 FEMORAL HEADS 01/28/2003
K003413 HOWMEDICA OSTEONICS CORP. ALUMINA V40 HEAD 11/24/2000
K993889 HOWMEDICA OSTEONICS CORP. EXETER CERAMIC FEMORAL HEADS 02/11/2000
K022403 HOWMEDICA OSTEONICS CORP. GMRS PRESS FIT STEMS WITH PUREFIX HA 10/17/2002
K040734 HOWMEDICA OSTEONICS CORP. MODIFICATION TO RESTORATION MODULAR SYSTEM 08/25/2004
K003391 HOWMEDICA OSTEONICS CORP. OSTEONICS ALUMINA C-TAPER HEAD 11/28/2000
K991952 HOWMEDICA OSTEONICS CORP. OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS 06/29/1999
K022549 HOWMEDICA OSTEONICS CORP. RESTORATION MODULAR SYSTEM 09/23/2002
K041170 HOWMEDICA OSTEONICS CORP. SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS 11/09/2004
K001449 HOWMEDICA OSTEONICS CORP. TRIDENT ACETABULAR SHELLS: PS 08/04/2000
K003379 HOWMEDICA OSTEONICS CORP. V-40/C-TAPER ADAPTER SLEEVE 11/30/2000
K213129 Howmedica Osteonics Corp., dba Stryker Orthopaedics Restoration Modular 115mm Conical Distal Stem 12/21/2021
K972228 HOWMEDICA, INC. MERIDIAN TITANIUM FEMORAL STEMS 12/05/1997
K980239 HOWMEDICA, INC. PARTNERSHIP CALCAR FEMORAL COMPONENTS 04/16/1998
K972361 HOWMEDICA, INC. V40 ZIRCONIA FEMORAL HEADS 09/23/1997
K151307 ICONACY ORTHOPEDIC IMPLANTS, LLC ICONACY(TM) I-Hip (TM) 02/26/2016
K223103 implantcast Gmbh BethaLoc« stem cementless HA 06/20/2023
K180263 implantcast Gmbh EcoFit Vit E Acetabular System 07/20/2018
K163577 Implantcast GmbH Ecofit« Hip System 09/25/2017
K203420 Implantcast, GmbH EcoFit« Hip System 02/03/2021
K210678 implantcast, GmbH implaFit« hip stems 08/17/2022
K990183 IMPLEX CORP. IMPLEX ALUMINA FEMORAL HEAD 06/11/1999
K955117 IMPLEX CORP. IMPLEX CERAMIC HEAD 04/05/1996
K961589 INTERMEDICS ORTHOPEDICS APR FULLY TEXTURED HIP STEM 07/09/1996
K961921 INTERMEDICS ORTHOPEDICS APR OVERSIZED HIP STEM 08/05/1996
K953690 INTERMEDICS ORTHOPEDICS CLS STEM (MODIFICATION) 06/07/1996
K961727 INTERMEDICS ORTHOPEDICS NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM 07/19/1996
K970166 INTERMEDICS ORTHOPEDICS NATURAL-HIP SYSTEM COCR REVISION STEM 04/08/1997
K964357 INTERMEDICS ORTHOPEDICS NATURAL-HIP SYSTEM COCR STEM 01/27/1997
K960588 INTERMEDICS ORTHOPEDICS WAGNER REVISION STEM 08/05/1996
K962101 INTERMEDICS ORTHOPEDICS ZWEYMUELLER SL FEMORAL HIP STEM 08/19/1996
K962248 JOHNSON & JOHNSON PROFESSIONALS, INC. P.F.C. CERAMIC HIP HEAD 08/29/1996
K973307 JOHNSON & JOHNSON PROFESSIONALS, INC. S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD 11/20/1997
K980081 JOHNSON & JOHNSON PROFESSIONALS, INC. S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD 04/09/1998
K970346 KAIROS ORTHOPAEDICS PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT 02/19/1997
K160895 KYOCERA Medical Corporation Initia Total Hip System & BIOCERAM AZUL(R) HEAD 11/01/2016
K970846 LANDOS, INC. 22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD 06/05/1997
K953111 LANDOS, INC. CORAIL 12/27/1996
K170473 Limacorporate S.p.A. C2 femoral stem 11/08/2017
K181491 Limacorporate S.p.A. Delta Dual Mobility System 05/09/2019
K140975 LIMACORPORATE S.P.A. MASTERSL FEMORAL STEM 06/10/2014
K143509 LIMACORPORATE S.P.A. MasterSL femoral stem 01/27/2015
K141327 LIMACORPORATE S.P.A. MINIMA S SYSTEM 08/06/2014
K231925 LimaCorporate S.p.A. MINIMA S System 07/11/2023
K151739 LIMACORPORATE S.P.A. Revision Femoral Stem 11/23/2015
K161226 LIMACORPORATE S.P.A. Revision Femoral Stem 02/10/2017
K183684 Maxx Orthopedics Inc. Libertas û Taper Uncemented Femoral Stem 08/23/2019
K183365 Maxx Orthopedics, Inc. Libertas Acetabular Hooded Liner 02/22/2019
K121011 MEDACTA INTERNATIONAL AMISTEM AND QUADRA - LINE EXTENSION 06/08/2012
K160289 MEDACTA INTERNATIONAL MasterLoc Stem 05/20/2016
K151531 MEDACTA INTERNATIONAL MasterLoc Stem 10/30/2015
K131518 MEDACTA INTERNATIONAL MECTACER BIOLOX OPTION HEADS 11/04/2013
K112115 MEDACTA INTERNATIONAL MECTACER BIOLOX(R) DELTA FEMORAL HEADS 10/07/2011
K131458 MEDACTA INTERNATIONAL MPACT DM LINER CONVERTER 10/01/2013
K122641 MEDACTA INTERNATIONAL MPACT EXTENSION 09/28/2012
K103352 MEDACTA INTERNATIONAL VERSAFITCUP CC TRIO 02/11/2011
K122911 MEDACTA INTERNATIONAL VERSAFITCUP CC TRIO EXTENSION 10/19/2012
K120531 MEDACTA INTERNATIONAL VERSAFITCUP CC TRIO-ADDITIONAL LINERS 04/18/2012
K220405 Medacta International S .A. Amis K Long 04/12/2022
K211891 Medacta International S.A. DM Converter - TiN coated 07/22/2022
K212327 Medacta International S.A. M-Vizion Monobloc 05/24/2022
K193433 Medacta International SA AMIStem-C 01/09/2020
K161635 MEDACTA INTERNATIONAL SA AMIStem-H Proximal Coating 03/31/2017
K173794 Medacta International SA AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared 03/14/2018
K192126 Medacta International SA AMIStem-P Short Neck 11/22/2019
K170690 Medacta International SA M-Vizion Femoral Revision System 11/29/2017
K191816 Medacta International SA M-Vizion Femoral Revision System Extension 04/29/2020
K201471 Medacta International SA M-Vizion Femoral Revision System Extension 01/11/2021
K191145 Medacta International SA MasterLoc Extension 05/30/2019
K173267 Medacta International SA MasterLoc Stem: Lateralized Plus 12/07/2017
K170845 Medacta International SA MiniMAX 08/08/2017
K192352 Medacta International SA MiniMAX 09/27/2019
K181254 Medacta International SA Quadra P 10/22/2018
K192827 Medacta International SA Quadra-P 01/06/2020
K202730 Medacta International SA Quadra-P 12/28/2020
K201673 Medacta International SA SMS Cementless Stem 09/18/2020
K203041 Medacta International SA SMS Cementless Stem 12/02/2020
K181693 Medacta International SA SMS Femoral Stem 11/28/2018
K073337 MEDACTA INTERNATIONAL, SA MECTACER BIOLOX FORTE-FEMORAL HEADS 02/13/2008
K103189 MEDACTA INTERNATIONAL, SA MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK 12/20/2010
K083558 MEDACTA INTERNATIONAL, SA MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C 03/06/2009
K093944 MEDACTA INTERNATIONAL, SA MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S 01/21/2010
K210263 MEDACTA INTERNATIONAL, SA Mpres Neck Preserving Stem 09/22/2021
K141377 MERETE MEDICAL GMBH BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD 11/21/2014
K123619 MERETE MEDICAL GMBH INTRABLOCK BIOBALL HIP SYSTEM (IBS) 05/24/2013
K183532 Meril Healthcare Pvt. Ltd. Latitud Hip Replacement System 07/18/2019
K173776 MicroPort Orthopedics Inc. BIOLOX delta Option and Extra-long Heads 07/06/2018
K140043 MICROPORT ORTHOPEDICS INC. DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD 04/03/2014
K181598 MicroPort Orthopedics Inc. Prime E-CLASS XLPE Liner 09/14/2018
K200007 MicroPort Orthopedics Inc. PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar 04/25/2020
K150302 MICROPORT ORTHOPEDICS INC. PROFEMUR Preserve Classic Stem 04/10/2015
K141235 MICROPORT ORTHOPEDICS INC. PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS 09/12/2014
K140676 MICROPORT ORTHOPEDICS INC. PROFEMUR TL CLASSIC LONG NECK HIP STEMS 05/30/2014
K191632 MicroPort Orthopedics Inc. PROFEMUR TL2 Stems 10/07/2019
K173898 MicroPort Orthopedics Inc. (MPO) MicroPort Orthopedics Total Hip Systems MR Labeling 09/20/2018
K171181 MicroPort Orthopedics, Inc. PROCOTYL« PRIME E-CLASSÖ XLPE Liner 08/28/2017
K150133 MICROPORT ORTHOPEDICS, INC. PROFEMUR Preserve Size 1-3 Hip Stems 04/20/2015
K090845 OMNI LIFE SCIENCE, INC. APEX ARC HIP STEM 04/07/2010
K101451 OMNI LIFE SCIENCE, INC. APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD 06/22/2010
K171156 OMNIlife science OMNI Anseris Hip Stem 08/17/2017
K172467 OMNIlife science OMNI ARC Anteverted Neck Hip Stem 12/21/2017
K133381 OMNILIFE SCIENCE OMNI ARC MONOBLOCK HIP STEM 03/13/2014
K111193 OMNILIFE SCIENCE INC. APEX ARC HIP STEM 06/27/2011
K152919 OMNILIFE SCIENCE INC. OMNI Skirted Heads 03/10/2016
K111936 ORTHO DEVELOPMENT ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD 09/21/2011
K971435 ORTHO DEVELOPMENT CORP. HEADLOC CERAMIC FEMORAL HEADS 07/09/1997
K970675 ORTHO DEVELOPMENT CORP. HEADLOC CERAMIC HEAD 08/22/1997
K971426 ORTHO DEVELOPMENT CORP. HEADLOC CERAMIC HEAD 07/09/1997
K060577 ORTHO DEVELOPMENT CORP. ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS 04/28/2006
K053587 ORTHO DEVELOPMENT CORP. ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS 03/17/2006
K052237 ORTHOPEDIC ALLIANCE LLC SC CERAMIC BALL HEADS 09/06/2005
K041443 OSTEOIMPLANT TECHNOLOGY, INC. OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM 11/16/2004
K003316 OSTEOIMPLANT TECHNOLOGY, INC. OTI CERAMIC FEMORAL HEAD SYSTEM 01/19/2001
K971409 OSTEONICS CORP. OSTEONICS ALUMINA C-TAPER HEAD 07/09/1997
K971497 OSTEONICS CORP. OSTEONICS ANTEVERTED NECK HIP STEM 07/16/1997
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K011836 PLUS ORTHOPEDICS MPF ACETABULAR CUP 09/07/2001
K022120 PLUS ORTHOPEDICS MPF ACETABULAR CUP GENERATION 2 07/24/2002
K990261 PLUS ORTHOPEDICS PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA) 08/27/1999
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K051223 STRYKER ORTHOPAEDICS HIPSTAR FEMORAL STEM 05/10/2006
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