510(k) Report

Devices descending from K932481

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K001942SL-Plus and SLR-Plus StemsPlus Orthopedics2000129—
+2K123598Smith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc.201302
+2K093991SLR-Plus Standard and Lateral Femoral StemsSmith & Nephew, Inc.20105—
+2K072852SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc.200827—
+2K072857Total Hip Prosthesis System Quadra S + Cocrmo Femoral Ball Head + ApricotMedacta International S.A.2008391
+2K060072Monoblock Press-Fit Hip StemOmni Life Science, Inc.200671
+2K052275Smith & Nephew Platform Hip StemSmith & Nephew, Inc.20051—
+2K041950Apex K2 Hip SystemApex Surgical, LLC2004621
+2K024134Uni Hip StemPlus Orthopedics20031—
+2K021178SL-Plus Lateralized StemPlus Orthopedics2002126—
+3K211176Smith & Nephew Hip SystemsSmith & Nephew, Inc.202231
+3K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell…Corin, Ltd.20212—
+3K170473C2 femoral stemLima Corporate S.P.A.20170—
+3K133370Remedy Hip Stem, Pegasus Hip Stem, Evolve Helios Hip Stem, Evolve Masters Hip Stem…Signature Orthopaedics Pty Limited20145—
+3K120211SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc.201218—
+3K121011Amistem and Quadra - Line ExtensionMedacta International201210—
+3K111145Endo HeadMedacta International20110—
+3K110947Apex K1 Hip StemOmni Life Science, Inc.20116—
+3K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+3K093944Medacta Total Hip Prothesis System-Amisten H , Quadra H, Quadra SMedacta International S.A.2010121
+3K083558Medacta Total Hip Prosthesis System - Quadra CMedacta International S.A.200991
+3K082792Medacta Total Hip Prosthesis System - Quadra H and R Femoral StemsMedacta International S.A.2008111
+3K080885Medacta Total Hip Prosthesis System - Line ExtensionMedacta International S.A.200822—
+4K250450Coated hip implantsMedacta International S.A.20250—
+4K243043Origin™ Cemented Hip StemSignature Orthopaedics Pty, Ltd.20250—
+4K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…Smith & Nephew, Inc.20240—
+4K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+4K241472Icona Hip StemCorin U.S.A. Limited20241—
+4K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+4K220405Amis K LongMedacta International S.A.20220—
+4K191708Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadSignature Orthopaedics Pty, Ltd.20200—
+4K192024Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.20200—
+4K192827Quadra-PMedacta International S.A.20206—
+4K181254Quadra PMedacta International S.A.20187—
+4K173794AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P CollaredMedacta International S.A.20189—
+4K161635AMIStem-H Proximal CoatingMedacta International S.A.201710—
+4K143096SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HASmith & Nephew, Inc.20153—
+4K143184Evolve UniPolar HeadSignature Orthopaedics Pty, Ltd.20151—
+4K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+4K130728Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc.2013111
+4K122296SL-Plus Mia Femoral Stems with TI/HA CoatingSmith & Nephew, Inc.20128—
+4K122244Polarcup Dual Mobility SystemSmith & Nephew, Inc.20125—
+4K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+4K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+4K103721Mpact Acetabular SystemMedacta International201121—
+4K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+4K103189Medacta Total Hip Prosthesis System - Amistem C & Quadra C Short NeckMedacta International S.A.201011
+5K253630Mpact 3D Metal FoamMedacta International S.A.20260—
+5K261576Icona Hip StemCorin, Ltd.20260—
+5K241461Mpact Constrained LinerMedacta International S.A.20251—
+5K251166Mfinity Femoral SystemMedacta International S.A.20250—
+5K230011Mpact ExtensionMedacta International S.A.20233—
+5K223103BethaLoc® stem cementless HAImplantcast GmbH20231—
+5K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+5K203175POLARSTEM Cemented Femoral StemSmith & Nephew, Inc.20210—
+5K200391MPACT ExtensionMedacta International S.A.20210—
+5K201047Fusion Taper SystemSignature Orthopaedics Pty, Ltd.20210—
+5K210062Mectaplug PE IIMedacta International S.A.20210—
+5K202730Quadra-PMedacta International S.A.20201—
+5K203041SMS Cementless StemMedacta International S.A.20201—
+5K193433AMIStem-CMedacta International S.A.20200—
+5K192126AMIStem-P Short NeckMedacta International S.A.20191—
+5K181491Delta Dual Mobility SystemLima Corporate S.P.A.20190—
+5K183582MPACT ExtensionMedacta International S.A.20194—
+5K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+5K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+5K171156OMNI Anseris Hip StemOmnilife Science20170—
+5K160011H-Max S stemLima Corporate S.P.A.20161—
+5K143739POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASmith & Nephew, Inc.201571
+5K143453Mpact Double Mobility SystemMedacta International20151—
+5K132879Mpact ExtensionMedacta International201411—
+5K122783Plasmafit Acetabular Cup and Vitelene InsertAesculap Implant System, Inc.20130—
+5K131458Mpact DM Liner ConverterMedacta International20133—
+5K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+5K122911Versafitcup CC Trio ExtensionMedacta International20121—
+5K122641Mpact ExtensionMedacta International201214—
+5K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+5K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+6K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.20260—
+6K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+6K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+6K240381CATALYSTEM Femoral StemsSmith & Nephew, Inc.20241—
+6K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+6K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+6K211891DM Converter - TiN coatedMedacta International S.A.20220—
+6K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+6K211548POLARSTEM Calcar Reamer GuideSmith & Nephew, Inc.20210—
+6K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+6K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+6K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+6K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+6K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+6K171249Entrada™ hip stemOrtho Development Corporation20172—
+6K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+6K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+7K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+7K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KG20250—
+7K250989Stryker and Serf hip devicesHowmedica Osteonics Corp (Dba Stryker Orthopaedics)20250—