FDA 510(k) Applications for Medical Device Product Code "MEH"
(Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate)

FDA 510(k) Number Applicant Device Name Decision Date
K043079 AESCULAP BICONTACT HIP SYSTEM WITH U-CAP 12/08/2004
K080584 AESCULAP IMPLANT SYSTEM, INC. METHA SHORT STEM HIP SYSTEM 05/09/2008
K092143 AESCULAP IMPLANT SYSTEMS, INC. EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM 09/22/2009
K071916 AESCULAP IMPLANT SYSTEMS, INC. METHA HIP SYSTEM 06/02/2008
K102424 AESCULAP IMPLANT SYSTEMS, LLC PREVISION HIP SYSTEM WITH RECON RING 12/09/2010
K060437 AESCULAP, INC. EXCIA TOTAL HIP SYSTEM WITH U-CAP 03/22/2006
K000262 BIOMET MANUFACTURING, INC. BOHN FEMORAL COMPONENT 04/03/2000
K021403 BIOMET ORTHOPEDICS, INC. HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM 05/31/2002
K020963 BIOMET ORTHOPEDICS, INC. TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM 04/16/2002
K001580 BIOMET, INC. GROSS FEMORAL COMPONENT 08/17/2000
K912370 BIOMET, INC. HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES) 10/11/1991
K912369 BIOMET, INC. HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT) 10/11/1991
K093472 CORIN U.S.A. TRINITY ACETABULAR SYSTEM 11/23/2010
K121563 CORIN USA CORIN TRIFIT TS HIP 10/05/2012
K173880 Corin USA Limited Corin TriFit CF Hip Stem 04/11/2018
K153772 CORIN USA LIMITED Corin TriFit TS Hip 03/31/2016
K160907 DEPUY (IRELAND) DePuy Actis DuoFix Hip Prosthesis 07/19/2016
K150862 DEPUY ORTHOPAEDICS, INC. DePuy Actis Duofox Hip Prosthesis 09/25/2015
K926299 DEPUY, INC. CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING 10/22/1993
K945844 DEPUY, INC. DEPUY CDH PROSTHESIS 05/25/1995
K910156 DEPUY, INC. HYDROXYAPATITE COATED PROFILE(R) HIP STEM 06/07/1991
K915655 DEPUY, INC. STABILITY FEMORAL PROSTHESIS W/HAP 02/14/1994
K912452 DOW CORNING WRIGHT HA MCCUTCHEN SLT HIP SYSTEM 10/04/1991
K915350 DOW CORNING WRIGHT HYDROXYAPATITE INFINITY TROCHANTERIC MODULE 02/03/1992
K920969 DOW CORNING WRIGHT HYDROXYLAPATITE INFINITY(R) 05/05/1993
K993943 ENCORE ORTHOPEDICS, INC. ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA 02/04/2000
K935696 ETEX CORP. ETEX HA HIP REPLACEMENT SYSTEM 07/22/1994
K162732 EXACTECH INC Exactech« Alteon« HA Femoral Stem 04/26/2017
K153649 EXACTECH INC Exactech« Novation« Element Press-fit Femoral Stem 08/31/2016
K000242 EXACTECH, INC. ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE 02/16/2000
K040613 EXACTECH, INC. EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS 06/04/2004
K080980 EXACTECH, INC. EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS 05/06/2008
K990197 EXACTECH, INC. MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM 02/04/1999
K113320 EXACTECH, INC. NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 03/16/2012
K961388 FOURNITURES HOSPITALIERES ATLAS III ACETABULAR CUP 04/03/1997
K021108 FOURNITURES HOSPITALIERES ESOP HA FEMORAL STEM 05/03/2002
K964878 FOURNITURES HOSPITALIERES ESOP S/C FEMORAL STEM 03/05/1998
K102172 GLOBAL MANUFACTURING TECHNOLOGY MSA HIP SYSTEM 03/01/2011
K113107 GLOBAL MANUFACTURING TECHNOLOGY MSA HIP SYSTEM 12/15/2011
K912395 HOWMEDICA CORP. HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT 07/24/1991
K955305 HOWMEDICA CORP. PCA +15MM MODULAR FEMORAL HEAD 01/18/1996
K112556 HOWMEDICA OSTEONICS CORP ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS 09/28/2011
K122853 HOWMEDICA OSTEONICS CORP NOVEL FIT AND FILL STEM 02/01/2013
K081044 HOWMEDICA OSTEONICS CORP REJUVENATE MODULAR HIP SYSTEM 06/03/2008
K092561 HOWMEDICA OSTEONICS CORP REJUVENATE MODULAR STEM 10/20/2009
K082892 HOWMEDICA OSTEONICS CORP REJUVENATE MONOLITHIC HIP SYSTEM 12/29/2008
K091161 HOWMEDICA OSTEONICS CORP REJUVENATE MONOLITHIC SIZE 4 HIP STEM 06/16/2009
K072020 HOWMEDICA OSTEONICS CORP RESTORATION ADM SYSTEM 10/18/2007
K092406 HOWMEDICA OSTEONICS CORP. ABG II MODULAR HIP STEM 11/04/2009
K020572 HOWMEDICA OSTEONICS CORP. ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM 03/04/2002
K023102 HOWMEDICA OSTEONICS CORP. ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM 10/09/2002
K032300 HOWMEDICA OSTEONICS CORP. ACCOLADE-J HIP STEM SERIES 10/09/2003
K993768 HOWMEDICA OSTEONICS CORP. CITATION TMZF HA STEM 01/21/2000
K993077 HOWMEDICA OSTEONICS CORP. HOWMEDICA OSTEONICS RESTORATION HA HIP STEM 10/08/1999
K992025 HOWMEDICA OSTEONICS CORP. PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING 08/13/1999
K093644 HOWMEDICA OSTEONICS CORP. RESTORATION ADM SYSTEM X3 ACETABULAR 12/18/2009
K020615 HOWMEDICA OSTEONICS CORP. SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS 05/13/2002
K994366 HOWMEDICA OSTEONICS CORP. TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM 03/16/2000
K001448 HOWMEDICA OSTEONICS CORP. TRIDENT ACETABULAR SHELLS: PS-HA 08/04/2000
K013676 HOWMEDICA OSTEONICS CORP. TRIDENT HEMISPHERICAL ACETABULAR SHELLS 12/05/2001
K915617 IMPLANT TECHNOLOGY, INC. LSF HA COATED FEMORAL HIP 05/28/1992
K181778 implantcast GmbH MUTARS Proximal Femur Replacement System 03/25/2019
K934729 IMPLANTOLOGY CORP. UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATED 07/22/1994
K071583 IMPLANTS INTERNATIONAL, LTD CERMET III ACETABULAR CUP SYSTEM 07/25/2007
K935990 IMPLEX CORP. F-220 PRESS-FIT FEMORAL HIP STEM SYSTEM 07/13/1994
K926134 IMPLEX CORP. H-220 PRESS-FIT ACETABULAR CUP SYSTEM 10/15/1993
K905781 INTERMEDICS ORTHOPEDICS APR AND APR II PRESS-FIT UNIVERSAL HIP SYSTEM 03/04/1991
K954800 INTERMEDICS ORTHOPEDICS APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) 04/25/1996
K910755 INTERMEDICS ORTHOPEDICS PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING 03/26/1991
K912713 JOINT MEDICAL PRODUCTS CORP. S-ROM ZT HA PROXIMAL FEMORAL SLEEVE 12/30/1991
K041353 JRI MANUFACTURING LTD FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM 10/08/2004
K914843 KINAMED, INC. KINAMED ATH-HA & ATH-HA LONG TOTAL HIP 02/03/1992
K912922 KIRSCHNER MEDICAL CORP. DIMENSION-HA HIP PROSTHESIS 10/04/1991
K921672 KIRSCHNER MEDICAL CORP. INTER-"HA" HIP PROSTHESIS 08/07/1992
K942891 KIRSCHNER MEDICAL CORP. SUMMIT TOTAL HIP SYSTEM 11/02/1994
K961732 LANDOS, INC. KAR 07/08/1997
K922613 LIMA INTL. CORP. CL HIP STEM H/A COATED 04/05/1994
K150855 Limacorporate S.P.A. H-MAX S Femoral Hip System 10/21/2015
K112091 LIMACORPORATE S.P.A. H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS 11/09/2012
K160011 LIMACORPORATE S.P.A. H-Max S stem 08/22/2016
K083116 MEDACTA INTERNATIONAL, SA VERSAFIT CUP DOUBLE MOBILITY SYSTEM 04/07/2009
K092265 MEDACTA INTERNATIONAL, SA VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS 03/12/2010
K171249 Ortho Development Corporation EntradaÖ hip stem 08/24/2017
K915190 ORTHOMET, INC. PERFECTA TOTAL HIP SYSTEM, HA COATED 12/24/1992
K912654 OSTEONICS CORP. OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP 08/16/1991
K911585 OSTEONICS CORP. OMNIFIT II EPF HIP STEM SERIES 07/01/1991
K911728 OSTEONICS CORP. OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C 08/16/1991
K971422 OSTEONICS CORP. OSTEONICS ACETABULAR WEDGE SYSTEM 05/22/1997
K980766 OSTEONICS CORP. OSTEONICS ANTEVERTED NECK HA HIP STEMS 05/27/1998
K983382 OSTEONICS CORP. OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM 12/11/1998
K980070 OSTEONICS CORP. OSTEONICS HA-COATED DEVICES 07/23/1999
K963959 OSTEONICS CORP. OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION) 12/19/1996
K970394 OSTEONICS CORP. OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM 04/22/1997
K941366 OSTEONICS CORP. OSTEONICS OMNIFIT AD-HA HIP STEM SERIES 06/06/1995
K982032 OSTEONICS CORP. OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS 07/09/1998
K990203 OSTEONICS CORP. OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS 02/18/1999
K983870 OSTEONICS CORP. OSTEONICS RESTORATION HA HIP STEMS 12/02/1998
K951291 OSTEONICS CORP. OSTEONICS RESTORATION MONOLITHIC HIP STEM 08/09/1995
K944836 OSTEONICS CORP. OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES 04/10/1995
K951932 OSTEONICS CORP. OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES 09/01/1995
K951671 OSTEONICS CORP. OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES 09/06/1995
K951517 OSTEONICS CORP. OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES 01/17/1996
K954023 OSTEONICS CORP. OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM 11/22/1995
K942900 OSTEONICS CORP. OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM 03/15/1995
K946234 OSTEONICS CORP. OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES 04/10/1995
K945691 OSTEONICS CORP. OSTEONICS(R) THREADED HA ACETABULAR SHELLS 03/17/1995
K943957 OSTEONICS CORP. RESTORATION HA ACETABULAR CUP SERIES 03/06/1995
K896047 OSTEONICS CORP. THE OMNIFIT EPF HIP JOINT FEMORAL STEM 12/20/1990
K032641 PORTLAND ORTHOPAEDICS PTY. LTD. MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM 01/20/2004
K992815 PORTLAND ORTHOPAEDICS PTY. LTD. THE MARGRON HIP REPLACEMENT SYSTEM 02/07/2000
K153131 SIGNATURE ORTHOPAEDICS PTY LTD. Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20? Hooded Acetabular Liner 06/03/2016
K161155 SIGNATURE ORTHOPAEDICS PTY LTD. Origin Coxa Vara Hip Stem 07/19/2016
K162303 SMITH & NEPHEW INC. REDAPT Sleeved Monolithic Revision Stems 05/01/2017
K922621 SMITH & NEPHEW RICHARDS, INC. HA TI-FIT ACETABULAR AND FEMORAL COMPONENT 03/17/1994
K913916 SMITH & NEPHEW RICHARDS, INC. HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT 12/09/1991
K040680 SMITH & NEPHEW, INC. CONTOUR HA COATED RECONSTRUCTION RING 06/14/2004
K023302 SMITH & NEPHEW, INC. ECHELON POROUS PLUS HA HIP STEMS 10/25/2002
K990666 SMITH & NEPHEW, INC. HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL 08/06/1999
K081124 SMITH & NEPHEW, INC. MDF REVISION HIP SYSTEM 07/31/2008
K113789 SMITH & NEPHEW, INC. MODULAR PROXIMALLY FLUTED HIP STEM 04/19/2012
K090982 SMITH & NEPHEW, INC. SMITH & NEPHEW HIP SYSTEMS WITH HA 04/21/2010
K100481 SMITH & NEPHEW, INC. SMITH & NEPHEW MDF MODULAR SLEEVE 07/15/2010
K042127 SMITH & NEPHEW, INC. SMITH & NEPHEW MODULAR HIP 11/19/2004
K052426 SMITH & NEPHEW, INC. SMITH & NEPHEW MODULAR HIP 12/07/2005
K113039 SMITH & NEPHEW, INC. SMITH & NEPHEW RADIOPAQUE TRIAL NECKS 10/05/2012
K121627 SMITH & NEPHEW, INC. SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM 10/15/2012
K002996 SMITH & NEPHEW, INC. SYNERGY HA COATED POROUS FEMORAL STEMS 12/11/2000
K970337 SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. HA GLOBAL TAPER (GT) TAPERED HIP STEM 02/28/1997
K103479 STRYKER CORP NOVEL TAPERED HIP STEM 03/10/2011
K053528 STRYKER ORTHOPAEDICS SHORT CITATION FEMORAL STEM 01/13/2006
K971523 SULZER ORTHOPEDICS, INC. DISTALLY FIXED HIP STEM 10/01/1997
K932017 TECHMEDICA, INC. TECHMEDICA CONTINUUM HIP WITH HA COATING 09/01/1994
K935453 U.S. MEDICAL PRODUCTS, INC. CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM 07/13/1994
K103497 UNITED ORTHOPEDIC CORP. CERAMIC FEMORAL HEAD 03/04/2011
K171273 Waldemar Link Gmbh & Co. KG LINK« BiMobile(TM) Dual Mobility System 01/19/2018
K912263 ZIMMER, INC. HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC 08/29/1991
K925607 ZIMMER, INC. HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE 11/08/1993


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