Panels › Orthopedic › Product code MEH · Class 2
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation 888.3353
2510(k)s in 12 months (160 all time)
1recalls in 12 months (197 all time)
190recalls that name a 510(k)
Top companies in MEH
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 10, 2026 | K261576 | Icona Hip Stem Corin, Ltd., GB | MEH |
| Nov 5, 2025 | K250375 | Allure Hip Stem and Intramedullary Plugs Waldemar Link GmbH & Co. KG, DE | MEH |
| Jun 13, 2025 | K251166 | Mfinity Femoral System Medacta International S.A., CH | MEH |
| May 22, 2025 | K251052 | Trivicta® Hip Stem Ortho Development Corp. | MEH |
| May 1, 2025 | K242315 | Resolve Modular Revision Hip Stem United Orthopedic Corporation, TW | MEH |
| Mar 10, 2025 | K243839 | Alteon® HA Femoral Stems Exactech, Inc. | MEH |
| Nov 25, 2024 | K243162 | World Liner Signature Orthopaedics Pty, Ltd., AU | MEH |
| Oct 3, 2024 | K241472 | Icona Hip Stem Corin U.S.A. Limited | MEH |
| Sep 13, 2024 | K241875 | TheRay Collared and Collarless Femoral Stem Nextstep Arthropedix | MEH |
| Aug 1, 2024 | K241690 | Logical Liner; World Liner; World Knee Patella Signature Orthopaedics Pty, Ltd., AU | MEH |
| Mar 8, 2024 | K233758 | Trivicta Hip Stem Ortho Development Corp. | MEH |
| Jan 19, 2024 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Depuy Ireland UC, IE | MEH |
| May 23, 2023 | K231178 | ACTERA hip system Conformis, Inc. | MEH |
| Jan 13, 2023 | K220495 | SignaSure Dual Mobility System Signature Orthopaedics Pty, Ltd., AU | MEH |
| Aug 11, 2022 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem Stryker | MEH |
| Aug 4, 2022 | K221104 | Actera hip system Conformis, Inc. | MEH |
| Jan 7, 2022 | K211742 | SignaSure Dual Mobility System Signature Orthopaedics Pty, Ltd., AU | MEH |
| Sep 24, 2021 | K211505 | Encore Hip Stem Signature Orthopaedics Pty, Ltd., AU | MEH |
| Aug 16, 2021 | K211703 | Insignia Hip Stem Stryker Orthopaedics | MEH |
| May 20, 2021 | K210581 | Actis DuoFix Hip Prosthesis- Collarless Depuy Ireland UC, IE | MEH |
| Oct 16, 2020 | K200045 | MUTARS Cemented Femoral Stems Implantcast GmbH, DE | MEH |
| Sep 21, 2020 | K201278 | World Hip Stem, World Cup, World Liner Signature Orthopaedics Pty, Ltd., AU | MEH |
| Feb 4, 2020 | K193398 | Summit DuoFix HA Coating DePuy Orthopaedics, Inc. | MEH |
| Mar 25, 2019 | K181778 | MUTARS Proximal Femur Replacement System Implantcast GmbH, DE | MEH |
| Apr 11, 2018 | K173880 | Corin TriFit CF Hip Stem Corin U.S.A. Limited | MEH |
| Jan 19, 2018 | K171273 | LINK® BiMobile(TM) Dual Mobility System Waldemar Link GmbH & Co. KG, DE | MEH |
| Aug 24, 2017 | K171249 | Entrada hip stem Ortho Development Corporation | MEH |
| May 1, 2017 | K162303 | REDAPT Sleeved Monolithic Revision Stems Smith & Nephew, Inc. | MEH |
| Apr 26, 2017 | K162732 | Exactech® Alteon® HA Femoral Stem Exactech, Inc. | MEH |
| Aug 31, 2016 | K153649 | Exactech® Novation® Element Press-fit Femoral Stem Exactech, Inc. | MEH |
| Aug 22, 2016 | K160011 | H-Max S stem Lima Corporate S.P.A., IT | MEH |
| Jul 19, 2016 | K161155 | Origin Coxa Vara Hip Stem Signature Orthopaedics Pty, Ltd., AU | MEH |
| Jul 19, 2016 | K160907 | DePuy Actis DuoFix Hip Prosthesis Depuy(Ireland), IE | MEH |
| Jun 3, 2016 | K153131 | Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Aceta Signature Orthopaedics Pty, Ltd., AU | MEH |
| Mar 31, 2016 | K153772 | Corin TriFit TS Hip Corin U.S.A. Limited | MEH |
| Oct 21, 2015 | K150855 | H-MAX S Femoral Hip System Lima Corporate S.P.A., IT | MEH |
| Sep 25, 2015 | K150862 | DePuy Actis Duofox Hip Prosthesis DePuy Orthopaedics, Inc. | MEH |
| Feb 1, 2013 | K122853 | NOVEL FIT AND FILL STEM Howmedica Osteonics Corp. | MEH |
| Nov 9, 2012 | K112091 | H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS Lima Corporate S.P.A. | MEH |
| Oct 15, 2012 | K121627 | SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM Smith & Nephew, Inc. | MEH |
| Oct 5, 2012 | K121563 | CORIN TRIFIT TS HIP Corin USA | MEH |
| Oct 5, 2012 | K113039 | SMITH & NEPHEW RADIOPAQUE TRIAL NECKS Smith & Nephew, Inc. | MEH |
| Apr 19, 2012 | K113789 | MODULAR PROXIMALLY FLUTED HIP STEM Smith & Nephew, Inc. | MEH |
| Mar 16, 2012 | K113320 | NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 Exactech, Inc. | MEH |
| Dec 15, 2011 | K113107 | MSA HIP SYSTEM Global Manufacturing Technology | MEH |
| Sep 28, 2011 | K112556 | ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS Howmedica Osteonics Corp. | MEH |
| Mar 10, 2011 | K103479 | NOVEL TAPERED HIP STEM Stryker Corp. | MEH |
| Mar 4, 2011 | K103497 | CERAMIC FEMORAL HEAD United Orthopedic Corp., TW | MEH |
| Mar 1, 2011 | K102172 | MSA HIP SYSTEM Global Manufacturing Technology | MEH |
| Dec 9, 2010 | K102424 | PREVISION HIP SYSTEM WITH RECON RING Aesculap Implant Systems, LLC | MEH |
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