510(k) Report

Devices descending from K910664

211 later devices reach Mod. Trochanter Screw & Washer W/ Anodized Titan. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+1K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc.1996210—
+2K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+2K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+2K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+2K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+2K070554Depuy Corail Amt Dysplasia Hip ProsthesisDePuy Orthopaedics, Inc.200749—
+2K061221Dupuy S-Rom STD Hip Stem ProsthesisDePuy Orthopaedics, Inc.20060—
+2K052426Smith & Nephew Modular HipSmith & Nephew, Inc.20056—
+2K042127Smith & Nephew Modular HipSmith & Nephew, Inc.200417—
+2K032730Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd.20040—
+2K992403MRP-TitanRotec Medizintechnik GmbH20000—
+2K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc.1998189—
+3K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+3K252067Velora Acetabular SystemRestor3D, Inc.20250—
+3K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+3K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+3K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+3K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+3K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc.20051—
+3K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc.2000188—
+4K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+4K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+4K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+4K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+4K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+4K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+4K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+4K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+4K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+4K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+4K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+4K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+4K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+4K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+4K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+4K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+4K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+4K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+4K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+4K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc.20051681
+4K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc.200423—
+4K033893Spectrum Modular SystemDePuy Orthopaedics, Inc.20048—
+4K011489Summit Duofix Hip ProsthesisDePuy Orthopaedics, Inc.200140—
+5K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+5K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+5K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+5K251166Mfinity Femoral SystemMedacta International S.A.20250—
+5K251052Trivicta® Hip StemOrtho Development Corp.20250—
+5K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+5K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K210678implaFit® hip stemsImplantcast GmbH20223—
+5K220216C-Stem AMT LE ProsthesisDepuy Ireland UC20228—
+5K211703Insignia Hip StemStryker Orthopaedics20217—
+5K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+5K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+5K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+5K183312Conformity StemUnited Orthopedic Corporation20193—
+5K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+5K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+5K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+5K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+5K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+5K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+5K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+5K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+5K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+5K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+5K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+5K130634Corin Metafix Hip StemCorin USA20135—
+5K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+5K123392Avenir Muller StemZimmer GmbH2013414
+5K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+5K112091H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.20126—
+5K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc20114—
+5K111910Gladiator Hip StemWrightmedicaltechnologyinc20115—
+5K093736Depuy Corail Hip System, Revision StemDePuy Orthopaedics, Inc.201114—
+5K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+5K102080Depuy Reclaim Revision Hip SystemDepuy (Ireland)201073
+5K082525Corin Metafix Femoral StemCorin USA2010712
+5K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc.200814—
+5K080991Depuy Asr XL Modular Acetabular Cup SystemDePuy Orthopaedics, Inc.2008041
+6K261576Icona Hip StemCorin, Ltd.20260—
+6K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+6K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+6K252401implaFit® short stemsImplantcast GmbH20260—
+6K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+6K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+6K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+6K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—