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 |
| 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 |
| K241472 | Corin USA Limited | Icona Hip Stem | 10/03/2024 |
| K160907 | DEPUY (IRELAND) | DePuy Actis DuoFix Hip Prosthesis | 07/19/2016 |
| K210581 | DePuy Ireland UC | Actis DuoFix Hip Prosthesis- Collarless | 05/20/2021 |
| K231873 | DePuy Ireland UC | DePuy SUMMIT Porocoat Hip Prosthesis û MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis û MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis û MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis û MR Conditional, DePuy SUMMIT Basic Press-Fit Hip P | 01/19/2024 |
| 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 |
| K243839 | Exactech, Inc. | Alteon« HA Femoral Stems | 03/10/2025 |
| 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 |
| K251166 | Medacta International S.A. | Mfinity Femoral System | 06/13/2025 |
| 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 |
| K241875 | NextStep Arthropedix | TheRay Collared and Collarless Femoral Stem | 09/13/2024 |
| K251052 | Ortho Development Corp. | Trivicta« Hip Stem | 05/22/2025 |
| K233758 | Ortho Development Corp. | TrivictaÖ Hip Stem | 03/08/2024 |
| 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 |
| K241690 | Signature Orthopaedics Pty Ltd | Logical Liner; World Liner; World Knee Patella | 08/01/2024 |
| K243162 | Signature Orthopaedics Pty Ltd | World Liner | 11/25/2024 |
| 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 |
| K242315 | United Orthopedic Corporation | Resolve Modular Revision Hip Stem | 05/01/2025 |
| K171273 | Waldemar Link Gmbh & Co. KG | LINK« BiMobile(TM) Dual Mobility System | 01/19/2018 |
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