510(k) Report

Devices descending from K954935

326 later devices reach S-Rom Femoral Hip Stem - Size 14 X 8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+1K052426Smith & Nephew Modular HipSmith & Nephew, Inc.20056—
+1K042127Smith & Nephew Modular HipSmith & Nephew, Inc.200417—
+1K032730Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd.20040—
+1K000788Apex Modular Hip StemApex Surgical, LLC2000168—
+1K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc.1998189—
+1K961939S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc.1996210—
+2K241472Icona Hip StemCorin U.S.A. Limited20241—
+2K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K101575Apex Modular Head, Size 28 ,32, 26 and 40 MM+10.5 Offset, Models 302810…Omnlife Science201024—
+2K100555Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNKOmni Life Science, Inc.2010341
+2K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+2K070554Depuy Corail Amt Dysplasia Hip ProsthesisDePuy Orthopaedics, Inc.200749—
+2K061221Dupuy S-Rom STD Hip Stem ProsthesisDePuy Orthopaedics, Inc.20060—
+2K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc.20051—
+2K043123Apex Modular HA Hip StemApex Surgical, LLC2005131—
+2K041950Apex K2 Hip SystemApex Surgical, LLC2004621
+2K041850Medallion Modular Hip SystemBiomet Manufacturing, Inc.20041—
+2K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc.2000188—
+2K992403MRP-TitanRotec Medizintechnik GmbH20000—
+3K261576Icona Hip StemCorin, Ltd.20260—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+3K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+3K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+3K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+3K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+3K191826KeYi Total Hip SystemBeijing Keyi Medical Device Technology Co., Ltd.20200—
+3K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+3K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+3K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+3K171249Entrada™ hip stemOrtho Development Corporation20172—
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+3K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+3K152919OMNI Skirted HeadsOmni Life Science, Inc.20161—
+3K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupSerf20153—
+3K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+3K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+3K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K101976Interface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc.201011
+3K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+3K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+3K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+3K071916Metha Hip SystemAesculap Implant Systems, Inc.2008681
+3K080842Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes]Omni Life Science, Inc.200861—
+3K060072Monoblock Press-Fit Hip StemOmni Life Science, Inc.200671
+3K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc.20051681
+3K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc.200423—
+3K033893Spectrum Modular SystemDePuy Orthopaedics, Inc.20048—
+3K011489Summit Duofix Hip ProsthesisDePuy Orthopaedics, Inc.200140—
+4K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K252067Velora Acetabular SystemRestor3D, Inc.20250—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+4K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+4K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+4K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+4K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+4K210678implaFit® hip stemsImplantcast GmbH20223—
+4K220216C-Stem AMT LE ProsthesisDepuy Ireland UC20228—
+4K211742SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20222—
+4K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+4K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+4K190904Conformis BeneFIT Hip SystemConformis, Inc.201961
+4K183312Conformity StemUnited Orthopedic Corporation20193—
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K182048Avenir Complete Hip SystemZimmer, Inc.20185—
+4K180973Libertas Hip Replacement SystemMaxx Orthopedics, Inc.20183—
+4K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+4K172857Latitud Hip Replacement SystemMeril Healthcare Pvt., Ltd.20185—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K162719iTotal® Hip Replacement SystemConformis, Inc.2017174
+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
+4K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K132879Mpact ExtensionMedacta International201411—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+4K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—