510(k) Report

Devices descending from K974331

189 later devices reach Uni-Rom Total Hip System Femoral Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc.2000188—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+2K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+2K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+2K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+2K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+2K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc.20051681
+2K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc.200423—
+2K033893Spectrum Modular SystemDePuy Orthopaedics, Inc.20048—
+2K011489Summit Duofix Hip ProsthesisDePuy Orthopaedics, Inc.200140—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+3K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+3K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+3K210678implaFit® hip stemsImplantcast GmbH20223—
+3K220216C-Stem AMT LE ProsthesisDepuy Ireland UC20228—
+3K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+3K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+3K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+3K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+3K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+3K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+3K183312Conformity StemUnited Orthopedic Corporation20193—
+3K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+3K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+3K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+3K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+3K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+3K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+3K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+3K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+3K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+3K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+3K130634Corin Metafix Hip StemCorin USA20135—
+3K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+3K123392Avenir Muller StemZimmer GmbH2013414
+3K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+3K112091H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.20126—
+3K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc20114—
+3K111910Gladiator Hip StemWrightmedicaltechnologyinc20115—
+3K093736Depuy Corail Hip System, Revision StemDePuy Orthopaedics, Inc.201114—
+3K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+3K102080Depuy Reclaim Revision Hip SystemDepuy (Ireland)201073
+3K082525Corin Metafix Femoral StemCorin USA2010712
+3K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc.200814—
+3K080991Depuy Asr XL Modular Acetabular Cup SystemDePuy Orthopaedics, Inc.2008041
+3K070554Depuy Corail Amt Dysplasia Hip ProsthesisDePuy Orthopaedics, Inc.200749—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+4K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+4K252401implaFit® short stemsImplantcast GmbH20260—
+4K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+4K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+4K251166Mfinity Femoral SystemMedacta International S.A.20250—
+4K251052Trivicta® Hip StemOrtho Development Corp.20250—
+4K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+4K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+4K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+4K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+4K243466Conformity Stem Extension Line, #0United Orthopedic Corporation20250—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+4K242249Conformity Stem Extension LineUnited Orthopedic Corporation20241—
+4K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+4K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K233476Z1 Hip SystemOrchard Medical Development202421
+4K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+4K232371Actinia® hip stemsImplantcast GmbH20231—
+4K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+4K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+4K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC20226—
+4K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+4K221104Actera™ hip systemConformis, Inc.202211
+4K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—
+4K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+4K211703Insignia Hip StemStryker Orthopaedics20217—
+4K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+4K201519PROFEMUR® GLADIATOR® Cemented Classic StemMicroport Orthopedics, Inc.20201—
+4K192989Libertas E-XLPE Modular LinerMaxx Orthopedics, Inc.20200—
+4K202484Cordera Hip SystemConformis, Inc.202022
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarMicroport Orthopedics, Inc.20201—
+4K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System)Waldemar Link GmbH & Co. KG20194—
+4K192189Avenir Complete Hip System, Size 0 Coxa VaraZimmer, Inc.20194—
+4K193030Avenir Muller Stem, Avenir Cemented Hip StemZimmer GmbH20193—
+4K192198Conformis Hip SystemConformis, Inc.2019121
+4K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+4K190704Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd.20192—
+4K183532Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20190—
+4K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+4K173898MicroPort Orthopedics Total Hip Systems MR LabelingMicroport Orthopedics Inc. (Mpo)20181—