510(k) Report

Devices descending from K001942

129 later devices reach SL-Plus and SLR-Plus Stems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+1K093991SLR-Plus Standard and Lateral Femoral StemsSmith & Nephew, Inc.20105—
+1K072852SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc.200827—
+1K072857Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + ApricotMedacta International S.A.2008391
+1K060072Monoblock Press-Fit Hip StemOmni Life Science, Inc.200671
+1K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc.20051—
+1K041950Apex K2 Hip SystemApex Surgical, LLC2004621
+1K024134Uni Hip StemPlus Orthopedics20031—
+1K021178SL-Plus Lateralized StemPlus Orthopedics2002126—
+2K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+2K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+2K170473C2 femoral stemLima Corporate S.P.A.20170—
+2K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+2K120211SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc.201218—
+2K121011Amistem and Quadra - Line ExtensionMedacta International201210—
+2K111145Endo HeadMedacta International20110—
+2K110947Apex K1 Hip StemOmni Life Science, Inc.20116—
+2K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+2K093944Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra SMedacta International S.A.2010121
+2K083558Medacta Total Hip Prosthesis System - Quadra CMedacta International S.A.200991
+2K082792Medacta Total Hip Prosthesis System - Quadra H and R Femoral StemsMedacta International S.A.2008111
+2K080885Medacta Total Hip Prosthesis System - Line ExtensionMedacta International S.A.200822—
+3K250450Coated hip implantsMedacta International S.A.20250—
+3K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+3K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+3K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+3K241472Icona Hip StemCorin U.S.A. Limited20241—
+3K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+3K220405Amis K LongMedacta International S.A.20220—
+3K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+3K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+3K192827Quadra-PMedacta International S.A.20206—
+3K181254Quadra PMedacta International S.A.20187—
+3K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+3K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+3K143096SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HASmith & Nephew, Inc.20153—
+3K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+3K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+3K130728Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc.2013111
+3K122296SL-Plus Mia Femoral Stems with TI/HA CoatingSmith & Nephew, Inc.20128—
+3K122244Polarcup Dual Mobility SystemSmith & Nephew, Inc.20125—
+3K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+3K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+3K103721Mpact Acetabular SystemMedacta International201121—
+3K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+3K103189Medacta Total Hip Prosthesis System - Amistem C & Quadra C Short NeckMedacta International S.A.201011
+4K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+4K261576Icona Hip StemCorin, Ltd.20260—
+4K241461Mpact Constrained LinerMedacta International S.A.20251—
+4K251166Mfinity Femoral SystemMedacta International S.A.20250—
+4K230011Mpact ExtensionMedacta International S.A.20233—
+4K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+4K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+4K203175POLARSTEM Cemented Femoral StemSmith & Nephew, Inc.20210—
+4K200391MPACT ExtensionMedacta International S.A.20210—
+4K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+4K210062Mectaplug PE IIMedacta International S.A.20210—
+4K202730Quadra-PMedacta International S.A.20201—
+4K203041SMS Cementless StemMedacta International S.A.20201—
+4K193433AMIStem-CMedacta International S.A.20200—
+4K192126AMIStem-P Short NeckMedacta International S.A.20191—
+4K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+4K183582MPACT ExtensionMedacta International S.A.20194—
+4K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+4K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+4K171156OMNI Anseris Hip StemOmnilife Science20170—
+4K160011H-Max S stemLima Corporate S.P.A.20161—
+4K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASmith & Nephew, Inc.201571
+4K143453Mpact Double Mobility SystemMedacta International20151—
+4K132879Mpact ExtensionMedacta International201411—
+4K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+4K131458Mpact DM Liner ConverterMedacta International20133—
+4K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+4K122911Versafitcup CC Trio ExtensionMedacta International20121—
+4K122641Mpact ExtensionMedacta International201214—
+4K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+4K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+5K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+5K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+5K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+5K240381CATALYSTEM Femoral StemsSmith & Nephew, Inc.20241—
+5K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+5K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+5K211891DM Converter - TiN coatedMedacta International S.A.20220—
+5K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+5K211548POLARSTEM Calcar Reamer GuideSmith & Nephew, Inc.20210—
+5K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+5K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+5K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+5K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+5K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+5K171249Entrada™ hip stemOrtho Development Corporation20172—
+5K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+5K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+6K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+6K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+6K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—
+6K251052Trivicta® Hip StemOrtho Development Corp.20250—