510(k) Report

Devices descending from K921301

383 later devices reach Taperloc Femoral Stem and Universal Acetabular Com through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K111481Corin Trinity Acetabular System Ecima LinersCorin USA2012331
+5K111911Corin Optimom Modular HeadCorin USA201162—
+5K102172Msa Hip SystemGlobal Manufacturing Technology20113—
+5K103256Smith & Nephew SMF Hip StemSmith & Nephew, Inc.2011162
+5K102424Prevision Hip System with Recon RingAesculap Implant Systems, LLC20100—
+5K100481Smith & Nephew MDF Modular SleeveSmith & Nephew, Inc.20105—
+5K090845Apex Arc Hip StemOmni Life Science, Inc.2010582
+5K090299Biolox Option Ceramic Femoral Head and Metha XL HeadsAesculap Implant Systems20091—
+5K083495Modification to: Metha Hip SystemAesculap Implant Systems, Inc.200959—
+5K082991Biolox Delta Ceramic Femoral HeadAesculap Implant Systems, Inc.200863—
+5K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc.20082—
+5K081973Metha Short Stem Hip System; Modular Hip System; Excia Hip SystemAesculap Implant Systems, Inc.20082—
+6K260831Z1 Hip SystemZimmer, Inc.20260—
+6K251906Z1 Hip SystemZimmer, Inc.20251—
+6K251166Mfinity Femoral SystemMedacta International S.A.20250—
+6K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet20241—
+6K243247Persona the Personalized Knee SystemZimmer, Inc.20240—
+6K242375OR3O Dual Mobility SystemSmith & Nephew, Inc.20240—
+6K231448TANDEM Hip SystemSmith & Nephew, Inc.202301
+6K230653Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and…Smith & Nephew, Inc.202331
+6K220376Acetabular Dome Hole PlugHowmedica Osteonics Corp., Dba Stryker Orthopaedics20225—
+6K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+6K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+6K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+6K191831MobiliT CupCorin U.S.A. Limited20203—
+6K192126AMIStem-P Short NeckMedacta International S.A.20191—
+6K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+6K181254Quadra PMedacta International S.A.20187—
+6K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+6K180334LEGION Knee SystemSmith & Nephew, Inc.20184—
+6K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc.20157—
+6K150062Excia Total Hip SystemAesculap Implant Systems, LLC20151—
+6K141821Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving…Exactech, Inc.201401
+6K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+6K123692Pipeline Knee SystemPipeline Orthopedics20130—
+6K123012Smith & Nephew SMF Hip StemSmith & Nephew, Inc.201210—
+6K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+6K113242Apex Arc Hip StemOmni Life Science, Inc.201252—
+6K113107Msa Hip SystemGlobal Manufacturing Technology20110—
+6K111193Apex Arc Hip StemOmni Life Science, Inc.201153—
+7K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+7K261462LANDMARK Total Knee SystemSmith & Nephew, Inc.20260—
+7K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics20260—
+7K243021Longboard Revision Hip StemSignature Orthopaedics Pty, Ltd.20250—
+7K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc.20240—
+7K242711JOURNEY II Unicompartmental Knee System (JOURNEY II UK)Smith & Nephew, Inc.20240—
+7K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+7K202730Quadra-PMedacta International S.A.20201—
+7K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+7K192827Quadra-PMedacta International S.A.20206—
+7K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+7K133381Omni Arc Monoblock Hip StemOmnilife Science20142—
+7K123991Depuy Corail Amt Hip ProsthesisDepuy France S.A.S.2013481
+7K130634Corin Metafix Hip StemCorin USA20135—
+7K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+8K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+8K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+8K220405Amis K LongMedacta International S.A.20220—
+8K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+8K210062Mectaplug PE IIMedacta International S.A.20210—
+8K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+8K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+8K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+8K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+8K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+8K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+8K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+8K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+9K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+9K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+9K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+9K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+9K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+9K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+9K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+9K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+9K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+9K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+10K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+10K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+10K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+10K221104Actera™ hip systemConformis, Inc.202211
+11K231178ACTERA™ hip systemConformis, Inc.20230—