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 |
K231178 |
Conformis Inc |
ACTERAÖ hip system |
05/23/2023 |
K221104 |
Conformis Inc. |
ActeraÖ hip system |
08/04/2022 |
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 |
K210581 |
DePuy Ireland UC |
Actis DuoFix Hip Prosthesis- Collarless |
05/20/2021 |
K150862 |
DEPUY ORTHOPAEDICS, INC. |
DePuy Actis Duofox Hip Prosthesis |
09/25/2015 |
K193398 |
DePuy Orthopaedics, Inc. |
Summit DuoFix HA Coating |
02/04/2020 |
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 |
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 |
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 |
K181778 |
implantcast GmbH |
MUTARS Proximal Femur Replacement System |
03/25/2019 |
K200045 |
implantcast, GmbH |
MUTARS Cemented Femoral Stems |
10/16/2020 |
K071583 |
IMPLANTS INTERNATIONAL, LTD |
CERMET III ACETABULAR CUP SYSTEM |
07/25/2007 |
K954800 |
INTERMEDICS ORTHOPEDICS |
APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI) |
04/25/1996 |
K041353 |
JRI MANUFACTURING LTD |
FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM |
10/08/2004 |
K961732 |
LANDOS, INC. |
KAR |
07/08/1997 |
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 |
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 |
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 |
K951517 |
OSTEONICS CORP. |
OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES |
01/17/1996 |
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 |
K211505 |
Signature Orthopaedics Pty Ltd. |
Encore Hip Stem |
09/24/2021 |
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 |
K211742 |
Signature Orthopaedics Pty Ltd. |
SignaSure Dual Mobility System |
01/07/2022 |
K220495 |
Signature Orthopaedics Pty Ltd. |
SignaSure Dual Mobility System |
01/13/2023 |
K201278 |
Signature Orthopaedics Pty Ltd. |
World Hip Stem, World Cup, World Liner |
09/21/2020 |
K162303 |
SMITH & NEPHEW INC. |
REDAPT Sleeved Monolithic Revision Stems |
05/01/2017 |
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 |
K220731 |
Stryker |
Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem |
08/11/2022 |
K103479 |
STRYKER CORP |
NOVEL TAPERED HIP STEM |
03/10/2011 |
K211703 |
Stryker Orthopaedics |
Insignia Hip Stem |
08/16/2021 |
K053528 |
STRYKER ORTHOPAEDICS |
SHORT CITATION FEMORAL STEM |
01/13/2006 |
K971523 |
SULZER ORTHOPEDICS, INC. |
DISTALLY FIXED HIP STEM |
10/01/1997 |
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 |