FDA Product Code
FDA Product Code MEH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3353
510(k) Clearances — 160 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261576 | Icona Hip Stem | Corin, Ltd. | 2026-08-10 | Traditional | PDF ↗ |
| K250375 | Allure Hip Stem and Intramedullary Plugs | Waldemar Link GmbH & Co. KG | 2025-11-05 | Traditional | PDF ↗ |
| K251166 | Mfinity Femoral System | Medacta International S.A. | 2025-06-13 | Traditional | PDF ↗ |
| K251052 | Trivicta® Hip Stem | Ortho Development Corp. | 2025-05-22 | Traditional | PDF ↗ |
| K242315 | Resolve Modular Revision Hip Stem | United Orthopedic Corporation | 2025-05-01 | Traditional | PDF ↗ |
| K243839 | Alteon® HA Femoral Stems | Exactech, Inc. | 2025-03-10 | Traditional | PDF ↗ |
| K243162 | World Liner | Signature Orthopaedics Pty, Ltd. | 2024-11-25 | Special | PDF ↗ |
| K241472 | Icona Hip Stem | Corin U.S.A. Limited | 2024-10-03 | Traditional | PDF ↗ |
| K241875 | TheRay Collared and Collarless Femoral Stem | Nextstep Arthropedix | 2024-09-13 | Traditional | PDF ↗ |
| K241690 | Logical Liner; World Liner; World Knee Patella | Signature Orthopaedics Pty, Ltd. | 2024-08-01 | Special | PDF ↗ |
| K233758 | Trivicta Hip Stem | Ortho Development Corp. | 2024-03-08 | Traditional | PDF ↗ |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional | Depuy Ireland UC | 2024-01-19 | Traditional | PDF ↗ |
| K231178 | ACTERA hip system | Conformis, Inc. | 2023-05-23 | Special | PDF ↗ |
| K220495 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2023-01-13 | Traditional | PDF ↗ |
| K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | Stryker | 2022-08-11 | Traditional | PDF ↗ |
| K221104 | Actera hip system | Conformis, Inc. | 2022-08-04 | Traditional | PDF ↗ |
| K211742 | SignaSure Dual Mobility System | Signature Orthopaedics Pty, Ltd. | 2022-01-07 | Traditional | PDF ↗ |
| K211505 | Encore Hip Stem | Signature Orthopaedics Pty, Ltd. | 2021-09-24 | Traditional | PDF ↗ |
| K211703 | Insignia Hip Stem | Stryker Orthopaedics | 2021-08-16 | Traditional | PDF ↗ |
| K210581 | Actis DuoFix Hip Prosthesis- Collarless | Depuy Ireland UC | 2021-05-20 | Traditional | PDF ↗ |
| K200045 | MUTARS Cemented Femoral Stems | Implantcast GmbH | 2020-10-16 | Traditional | PDF ↗ |
| K201278 | World Hip Stem, World Cup, World Liner | Signature Orthopaedics Pty, Ltd. | 2020-09-21 | Traditional | PDF ↗ |
| K193398 | Summit DuoFix HA Coating | DePuy Orthopaedics, Inc. | 2020-02-04 | Special | PDF ↗ |
| K181778 | MUTARS Proximal Femur Replacement System | Implantcast GmbH | 2019-03-25 | Traditional | PDF ↗ |
| K173880 | Corin TriFit CF Hip Stem | Corin U.S.A. Limited | 2018-04-11 | Traditional | PDF ↗ |
| K171273 | LINK® BiMobile(TM) Dual Mobility System | Waldemar Link GmbH & Co. KG | 2018-01-19 | Traditional | PDF ↗ |
| K171249 | Entrada hip stem | Ortho Development Corporation | 2017-08-24 | Traditional | PDF ↗ |
| K162303 | REDAPT Sleeved Monolithic Revision Stems | Smith & Nephew, Inc. | 2017-05-01 | Abbreviated | PDF ↗ |
| K162732 | Exactech® Alteon® HA Femoral Stem | Exactech, Inc. | 2017-04-26 | Traditional | PDF ↗ |
| K153649 | Exactech® Novation® Element Press-fit Femoral Stem | Exactech, Inc. | 2016-08-31 | Traditional | PDF ↗ |
| K160011 | H-Max S stem | Lima Corporate S.P.A. | 2016-08-22 | Traditional | PDF ↗ |
| K160907 | DePuy Actis DuoFix Hip Prosthesis | Depuy(Ireland) | 2016-07-19 | Traditional | PDF ↗ |
| K161155 | Origin Coxa Vara Hip Stem | Signature Orthopaedics Pty, Ltd. | 2016-07-19 | Traditional | PDF ↗ |
| K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner | Signature Orthopaedics Pty, Ltd. | 2016-06-03 | Traditional | PDF ↗ |
| K153772 | Corin TriFit TS Hip | Corin U.S.A. Limited | 2016-03-31 | Traditional | PDF ↗ |
| K150855 | H-MAX S Femoral Hip System | Lima Corporate S.P.A. | 2015-10-21 | Special | PDF ↗ |
| K150862 | DePuy Actis Duofox Hip Prosthesis | DePuy Orthopaedics, Inc. | 2015-09-25 | Traditional | PDF ↗ |
| K122853 | NOVEL FIT AND FILL STEM | Howmedica Osteonics Corp. | 2013-02-01 | Traditional | PDF ↗ |
| K112091 | H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS | Lima Corporate S.P.A. | 2012-11-09 | Traditional | PDF ↗ |
| K121627 | SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM | Smith & Nephew, Inc. | 2012-10-15 | Abbreviated | PDF ↗ |
| K121563 | CORIN TRIFIT TS HIP | Corin USA | 2012-10-05 | Traditional | PDF ↗ |
| K113039 | SMITH & NEPHEW RADIOPAQUE TRIAL NECKS | Smith & Nephew, Inc. | 2012-10-05 | Traditional | PDF ↗ |
| K113789 | MODULAR PROXIMALLY FLUTED HIP STEM | Smith & Nephew, Inc. | 2012-04-19 | Abbreviated | PDF ↗ |
| K113320 | NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 | Exactech, Inc. | 2012-03-16 | Special | PDF ↗ |
| K113107 | MSA HIP SYSTEM | Global Manufacturing Technology | 2011-12-15 | Special | PDF ↗ |
| K112556 | ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS | Howmedica Osteonics Corp. | 2011-09-28 | Special | PDF ↗ |
| K103479 | NOVEL TAPERED HIP STEM | Stryker Corp. | 2011-03-10 | Traditional | PDF ↗ |
| K103497 | CERAMIC FEMORAL HEAD | United Orthopedic Corp. | 2011-03-04 | Traditional | PDF ↗ |
| K102172 | MSA HIP SYSTEM | Global Manufacturing Technology | 2011-03-01 | Traditional | PDF ↗ |
| K102424 | PREVISION HIP SYSTEM WITH RECON RING | Aesculap Implant Systems, LLC | 2010-12-09 | Traditional | PDF ↗ |
| K093472 | TRINITY ACETABULAR SYSTEM | Corin USA | 2010-11-23 | Traditional | PDF ↗ |
| K100481 | SMITH & NEPHEW MDF MODULAR SLEEVE | Smith & Nephew, Inc. | 2010-07-15 | Abbreviated | PDF ↗ |
| K090982 | SMITH & NEPHEW HIP SYSTEMS WITH HA | Smith & Nephew, Inc. | 2010-04-21 | Abbreviated | PDF ↗ |
| K092265 | VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS | Medacta International S.A. | 2010-03-12 | Traditional | PDF ↗ |
| K093644 | RESTORATION ADM SYSTEM X3 ACETABULAR | Howmedica Osteonics Corp. | 2009-12-18 | Special | PDF ↗ |
| K092406 | ABG II MODULAR HIP STEM | Howmedica Osteonics Corp. | 2009-11-04 | Traditional | PDF ↗ |
| K092561 | REJUVENATE MODULAR STEM | Howmedica Osteonics Corp. | 2009-10-20 | Special | PDF ↗ |
| K092143 | EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM | Aesculap Implant Systems, Inc. | 2009-09-22 | Special | PDF ↗ |
| K091161 | REJUVENATE MONOLITHIC SIZE 4 HIP STEM | Howmedica Osteonics Corp. | 2009-06-16 | Traditional | PDF ↗ |
| K083116 | VERSAFIT CUP DOUBLE MOBILITY SYSTEM | Medacta International S.A. | 2009-04-07 | Traditional | PDF ↗ |
| K082892 | REJUVENATE MONOLITHIC HIP SYSTEM | Howmedica Osteonics Corp. | 2008-12-29 | Traditional | PDF ↗ |
| K081124 | MDF REVISION HIP SYSTEM | Smith & Nephew, Inc. | 2008-07-31 | Abbreviated | PDF ↗ |
| K081044 | REJUVENATE MODULAR HIP SYSTEM | Howmedica Osteonics Corp. | 2008-06-03 | Special | PDF ↗ |
| K071916 | METHA HIP SYSTEM | Aesculap Implant Systems, Inc. | 2008-06-02 | Traditional | PDF ↗ |
| K080584 | METHA SHORT STEM HIP SYSTEM | Aesculap Implant System, Inc. | 2008-05-09 | Traditional | PDF ↗ |
| K080980 | EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS | Exactech, Inc. | 2008-05-06 | Special | PDF ↗ |
| K072020 | RESTORATION ADM SYSTEM | Howmedica Osteonics Corp. | 2007-10-18 | Traditional | PDF ↗ |
| K071583 | CERMET III ACETABULAR CUP SYSTEM | Implants International, Ltd. | 2007-07-25 | Traditional | PDF ↗ |
| K060437 | EXCIA TOTAL HIP SYSTEM WITH U-CAP | Aesculap, Inc. | 2006-03-22 | Special | PDF ↗ |
| K053528 | SHORT CITATION FEMORAL STEM | Stryker Orthopaedics | 2006-01-13 | Special | PDF ↗ |
| K052426 | SMITH & NEPHEW MODULAR HIP | Smith & Nephew, Inc. | 2005-12-07 | Abbreviated | PDF ↗ |
| K043079 | BICONTACT HIP SYSTEM WITH U-CAP | Aesculap | 2004-12-08 | Special | PDF ↗ |
| K042127 | SMITH & NEPHEW MODULAR HIP | Smith & Nephew, Inc. | 2004-11-19 | Abbreviated | PDF ↗ |
| K041353 | FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM | Jri Manufacturing, Ltd. | 2004-10-08 | Traditional | PDF ↗ |
| K040680 | CONTOUR HA COATED RECONSTRUCTION RING | Smith & Nephew, Inc. | 2004-06-14 | Traditional | PDF ↗ |
| K040613 | EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS | Exactech, Inc. | 2004-06-04 | Special | PDF ↗ |
| K032641 | MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM | Portland Orthopaedics Pty. , Ltd. | 2004-01-20 | Special | PDF ↗ |
| K032300 | ACCOLADE-J HIP STEM SERIES | Howmedica Osteonics Corp. | 2003-10-09 | Traditional | PDF ↗ |
| K023302 | ECHELON POROUS PLUS HA HIP STEMS | Smith & Nephew, Inc. | 2002-10-25 | Special | PDF ↗ |
| K023102 | ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM | Howmedica Osteonics Corp. | 2002-10-09 | Special | PDF ↗ |
| K021403 | HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM | Biomet Orthopedics, Inc. | 2002-05-31 | Special | PDF ↗ |
| K020615 | SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS | Howmedica Osteonics Corp. | 2002-05-13 | Special | PDF ↗ |
| K021108 | ESOP HA FEMORAL STEM | Fournitures Hospitalieres | 2002-05-03 | Special | PDF ↗ |
| K020963 | TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM | Biomet Orthopedics, Inc. | 2002-04-16 | Special | PDF ↗ |
| K020572 | ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM | Howmedica Osteonics Corp. | 2002-03-04 | Special | PDF ↗ |
| K013676 | TRIDENT HEMISPHERICAL ACETABULAR SHELLS | Howmedica Osteonics Corp. | 2001-12-05 | Special | PDF ↗ |
| K002996 | SYNERGY HA COATED POROUS FEMORAL STEMS | Smith & Nephew, Inc. | 2000-12-11 | Abbreviated | PDF ↗ |
| K001580 | GROSS FEMORAL COMPONENT | Biomet, Inc. | 2000-08-17 | Traditional | PDF ↗ |
| K001448 | TRIDENT ACETABULAR SHELLS: PS-HA | Howmedica Osteonics Corp. | 2000-08-04 | Traditional | PDF ↗ |
| K000262 | BOHN FEMORAL COMPONENT | Biomet Manufacturing, Inc. | 2000-04-03 | Traditional | PDF ↗ |
| K994366 | TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM | Howmedica Osteonics Corp. | 2000-03-16 | Traditional | PDF ↗ |
| K000242 | ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE | Exactech, Inc. | 2000-02-16 | Special | PDF ↗ |
| K992815 | THE MARGRON HIP REPLACEMENT SYSTEM | Portland Orthopaedics Pty. , Ltd. | 2000-02-07 | Traditional | PDF ↗ |
| K993943 | ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA | Encore Orthopedics, Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K993768 | CITATION TMZF HA STEM | Howmedica Osteonics Corp. | 2000-01-21 | Traditional | PDF ↗ |
| K993077 | HOWMEDICA OSTEONICS RESTORATION HA HIP STEM | Howmedica Osteonics Corp. | 1999-10-08 | Special | PDF ↗ |
| K992025 | PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING | Howmedica Osteonics Corp. | 1999-08-13 | Traditional | PDF ↗ |
| K990666 | HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL | Smith & Nephew, Inc. | 1999-08-06 | Abbreviated | PDF ↗ |
| K980070 | OSTEONICS HA-COATED DEVICES | Osteonics Corp. | 1999-07-23 | Traditional | PDF ↗ |
| K990203 | OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS | Osteonics Corp. | 1999-02-18 | Special | PDF ↗ |
Product code MEH · Class II · Orthopedic. Data: openFDA.