510(k) Report

Devices descending from K913231

329 later devices reach S-Rom (TM) Total Lhip System W/Ceramic Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032730Fixion Hip SystemDisc-O-Tech Medical Technologies, Ltd.20040—
+1K000788Apex Modular Hip StemApex Surgical, LLC2000168—
+1K992815The Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd.2000171
+1K980020Activelock Modular Femoral Hip SystemMetagen, LLC19982—
+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—
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K171156OMNI Anseris Hip StemOmnilife Science20170—
+2K162303REDAPT Sleeved Monolithic Revision StemsSmith & Nephew, Inc.20174—
+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
+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—
+2K043123Apex Modular HA Hip StemApex Surgical, LLC2005131—
+2K041950Apex K2 Hip SystemApex Surgical, LLC2004621
+2K041850Medallion Modular Hip SystemBiomet Manufacturing, Inc.20041—
+2K042127Smith & Nephew Modular HipSmith & Nephew, Inc.200417—
+2K032641Modification to: the Margron Hip Replacement SystemPortland Orthopaedics Pty., Ltd.2004071
+2K992403MRP-TitanRotec Medizintechnik GmbH20000—
+2K974331Uni-Rom Total Hip System Femoral StemJohnson & Johnson Professionals, Inc.1998189—
+3K261576Icona Hip StemCorin, Ltd.20260—
+3K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+3K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+3K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+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—
+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
+3K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K101976Interface Acetabular System, Acetabular Insert +4 OffsetOmni Life Science, Inc.201011
+3K101451Apex Module Hip System Biolox Delta Femoral HeadOmni Life Science, Inc.20104—
+3K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+3K081124MDF Revision Hip SystemSmith & Nephew, Inc.2008142
+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
+3K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc.20051—
+3K001991Titan Porocoat Hip ProsthesisDePuy Orthopaedics, Inc.2000188—
+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—
+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—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+4K220495SignaSure Dual Mobility SystemSignature Orthopaedics Pty, Ltd.20231—
+4K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+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—
+4K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+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—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+4K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+4K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K132879Mpact ExtensionMedacta International201411—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+4K131458Mpact DM Liner ConverterMedacta International20133—
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc.201251
+4K113039Smith & Nephew Radiopaque Trial NecksSmith & Nephew, Inc.20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc.201281
+4K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K112682Metha Hip SystemAesculap Implant Systems, LLC20122—
+4K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+4K111145Endo HeadMedacta International20110—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K110947Apex K1 Hip StemOmni Life Science, Inc.20116—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+4K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+4K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+4K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+4K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+4K042992Corail Amt Hip ProsthesisDePuy Orthopaedics, Inc.20051681
+4K042959Depuy C-Stem Amt Hip ProsthesisDePuy Orthopaedics, Inc.200423—
+4K033893Spectrum Modular SystemDePuy Orthopaedics, Inc.20048—