510(k) Report

Devices descending from K935452

213 later devices reach P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc.1998189—
+1K945518P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc.1996212—
+2K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc.2000188—
+2K982812G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc.19980—
+2K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc.1996210—
+3K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+3K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+3K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+3K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+3K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+3K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+3K070554Depuy Corail Amt Dysplasia Hip ProsthesisDePuy Orthopaedics, Inc.200749—
+3K061221Dupuy S-Rom STD Hip Stem ProsthesisDePuy Orthopaedics, Inc.20060—
+3K052426Smith & Nephew Modular HipSmith & Nephew, Inc.20056—
+3K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc.20051681
+3K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc.200423—
+3K042127Smith & Nephew Modular HipSmith & Nephew, Inc.200417—
+3K032730Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd.20040—
+3K033893Spectrum Modular SystemDePuy Orthopaedics, Inc.20048—
+3K011489Summit Duofix Hip ProsthesisDePuy Orthopaedics, Inc.200140—
+3K992403MRP-TitanRotec Medizintechnik GmbH20000—
+4K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+4K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+4K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+4K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+4K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K220216C-Stem AMT LE ProsthesisDepuy Ireland UC20228—
+4K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+4K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+4K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+4K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+4K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+4K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+4K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+4K183312Conformity StemUnited Orthopedic Corporation20193—
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+4K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+4K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+4K171249Entrada™ hip stemOrtho Development Corporation20172—
+4K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+4K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+4K161155Origin Coxa Vara Hip StemSignature Orthopaedics Pty, Ltd.201611
+4K152084Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) &…Corentec Co., Ltd.201671
+4K153381Corin Metafix Hip StemCorin U.S.A. Limited201651
+4K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+4K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+4K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+4K130634Corin Metafix Hip StemCorin USA20135—
+4K123782Paragon Hip SystemGlobal Manufacturing Technology20132—
+4K123392Avenir Muller StemZimmer GmbH2013414
+4K121297Origin Hip Stem, Femoral Head, Logical PX-Series Acetabular Shell, Locigal G-Series…Signature Orthopaedics Pty, Ltd.2012202
+4K112091H-Max S Femoral Stems, Modular Femoral Heads, Cemented Cups, Lock Bipolar HeadsLima Corporate S.P.A.20126—
+4K112150Profemur Gladiator HA Hip StemWrightmedicaltechnologyinc20114—
+4K111910Gladiator Hip StemWrightmedicaltechnologyinc20115—
+4K093736Depuy Corail Hip System, Revision StemDePuy Orthopaedics, Inc.201114—
+4K101472Multifit Total Hip SystemOtis Biotech Co., Ltd.20110—
+4K102080Depuy Reclaim Revision Hip SystemDepuy (Ireland)201073
+4K082525Corin Metafix Femoral StemCorin USA2010712
+4K082239Depuy C-Stem AmtDePuy Orthopaedics, Inc.200814—
+4K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+4K080991Depuy Asr XL Modular Acetabular Cup SystemDePuy Orthopaedics, Inc.2008041
+4K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc.20051—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+5K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+5K252401implaFit® short stemsImplantcast GmbH20260—
+5K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.20260—
+5K252067Velora Acetabular SystemRestor3D, Inc.20250—
+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—
+5K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+5K242315Resolve Modular Revision Hip StemUnited Orthopedic Corporation20250—
+5K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+5K243466Conformity Stem Extension Line, #0United Orthopedic Corporation20250—
+5K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+5K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+5K241472Icona Hip StemCorin U.S.A. Limited20241—
+5K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+5K242249Conformity Stem Extension LineUnited Orthopedic Corporation20241—
+5K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+5K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsMicroport Orthopedics20240—
+5K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+5K233476Z1 Hip SystemOrchard Medical Development202421
+5K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+5K232371Actinia® hip stemsImplantcast GmbH20231—
+5K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+5K231109Xerxes Hip StemXerxes Arthopedix, LLC20230—
+5K222436Latitud™ Hip Replacement SystemMeril Healthcare Pvt., Ltd.20230—
+5K221462DePuy Reclaim Monobloc Revision Femoral StemDepuy Ireland UC20226—
+5K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+5K221104Actera™ hip systemConformis, Inc.202211
+5K220468BENCOX Mirabo Cup SystemCorentec Co., Ltd.20221—