510(k) Report

Devices descending from K010757

300 later devices reach Lfit V40 Femoral Head Components through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc.20251—
+7K223745Novae® Dual Mobility System, Hype® Hip SystemSerf20231—
+7K231526CORAIL Cemented Femoral StemDepuy Ireland UC20230—
+7K230011Mpact ExtensionMedacta International S.A.20233—
+7K231037MyKnee UNI-STMedacta International S.A.20230—
+7K212069Corin MetaFix™ Hip StemCorin U.S.A. Limited20222—
+7K202568Mpact® 3D Metal Implants - DMLS TechnologyMedacta International S.A.20211—
+7K211657EMPHASYS Femoral StemsDepuy Ireland UC20217—
+7K200391MPACT ExtensionMedacta International S.A.20210—
+7K210010GMK Revision & Hinge Extension - TiNbN CoatingMedacta International S.A.20211—
+7K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+7K203167DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20202—
+7K193545Corin Optimized Positioning System (OPS) FemoralCorin USA20200—
+7K193559NextAR TKA PlatformMedacta Inernational SA202012—
+7K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics20203—
+7K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+7K192656Optimized Positioning System (OPS) InsightCorin USA20203—
+7K191831MobiliT CupCorin U.S.A. Limited20203—
+7K192946DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.201910—
+7K190344DePuy Corail AMT Hip ProsthesisDepuy (Ireland)201911—
+7K190890Exactech Alteon Modular Dual Mobility (MDM) SystemExactech, Inc.20190—
+7K183582MPACT ExtensionMedacta International S.A.20194—
+7K173960DePuy Corail AMT Hip ProsthesisDepuy France S.A.S.201814—
+7K170339Summit Hip SystemDePuy Orthopaedics, Inc.201827—
+7K171966Mpact® 3D Metal™ Implants and Augments 3D Metal™Medacta International S.A.20183—
+7K173583Exactech® Novation® and AcuMatch® E-HXL Acetabular LinersExactech, Inc.201833
+7K172467OMNI ARC Anteverted Neck Hip StemOmnilife Science20170—
+7K172347GMK Hinge, GMK RevisionMedacta International S.A.20172—
+7K170106MyKnee PPS-Pin PositionersMedacta International S.A.20172—
+7K171249Entrada™ hip stemOrtho Development Corporation20172—
+7K171156OMNI Anseris Hip StemOmnilife Science20170—
+7K162942Corin MetaFix Hip StemCorin U.S.A. Limited20173—
+7K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip…Waldemar Link GmbH & Co. KG20171—
+7K163311GMK Revision Femoral Distal AugmentationMedacta International S.A.20162—
+7K161184iNSitu Total Hip SystemTheken Companies, LLC201619—
+7K150862DePuy Actis Duofox Hip ProsthesisDePuy Orthopaedics, Inc.2015381
+7K143453Mpact Double Mobility SystemMedacta International20151—
+7K132879Mpact ExtensionMedacta International201411—
+7K131116U2 Total Knee System - Psa Type, Offset Stem AdapterUnited Orthopedic Corporation20130—
+7K131458Mpact DM Liner ConverterMedacta International20133—
+7K123692Pipeline Knee SystemPipeline Orthopedics20130—
+7K122911Versafitcup CC Trio ExtensionMedacta International20121—
+7K122641Mpact ExtensionMedacta International201214—
+7K120362Metafix Femoral Stem for Hemi-ArthroplastyCorin USA201261—
+7K120531Versafitcup CC Trio-Additional LinersMedacta International20122—
+7K111145Endo HeadMedacta International20110—
+8K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.20260—
+8K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc.20260—
+8K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics20260—
+8K254043TRIVANCE™ Hip StemGlobus Medical, Inc.20260—
+8K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+8K252847NextAR Hip PlatformMedacta International S.A.20260—
+8K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+8K251166Mfinity Femoral SystemMedacta International S.A.20250—
+8K251052Trivicta® Hip StemOrtho Development Corp.20250—
+8K250444NEXUS® Hip StemMicroport Orthopedics, Inc.20250—
+8K242232Mpact 3D Metal Augments IIMedacta International S.A.20250—
+8K243029Origin™ TT StemSignature Orthopaedics Pty, Ltd.20250—
+8K241767Versacem Acetabular Shell and Double Mobility HC LinersMedacta International S.A.20250—
+8K241875TheRay Collared and Collarless Femoral StemNextstep Arthropedix202411
+8K233758Trivicta™ Hip StemOrtho Development Corp.20241—
+8K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC20245—
+8K233233EMPHASYS Femoral StemsDepuy Ireland UC20230—
+8K220336Mg-PSZ Ceramic Femoral HeadTheken Companies20220—
+8K213770SP-CL Hip Stem and LCU Hip SystemWaldemar Link GmbH & Co. KG20220—
+8K211891DM Converter - TiN coatedMedacta International S.A.20220—
+8K220705MyKnee R Pin PositionersMedacta International S.A.20220—
+8K213751NextAR™ TKA Platform My Knee PPSMedacta International S.A.20220—
+8K213839DePuy Corail AMT Hip ProsthesisDePuy Orthopaedics, Inc.20220—
+8K210859NextAR™ Spine PlatformMedacta International S.A.20214—
+8K211703Insignia Hip StemStryker Orthopaedics20217—
+8K210653ONE Planner HipOrthosoft D/B/A Zimmer Cas20210—
+8K210581Actis DuoFix Hip Prosthesis- CollarlessDepuy Ireland UC202113—
+8K210153NextAR RSA PlatformMedacta International S.A.202151
+8K202805Optimized Positioning System (OPS) InsightCorin USA20200—
+8K202152NextAR TKA PlatformMedacta International S.A.202011—
+8K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+8K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+8K192071iNSitu Total Hip SystemTheken Companies, LLC20194—
+8K191936iNSitu Total Hip SystemThecken Companies, LLC20192—
+8K182502Alteon Acetabular Cup SystemExactech, Inc.201922
+8K172501iNSitu Total Hip SystemTheken Companies, LLC20177—
+8K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+8K130634Corin Metafix Hip StemCorin USA20135—
+8K121439Metafix Femoral Hip Stem Size 1Corin USA20128—
+9K250477NextAR (TM) SpineMedacta International S.A.20250—
+9K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+9K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+9K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+9K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+9K241690Logical Liner; World Liner; World Knee PatellaSignature Orthopaedics Pty, Ltd.20242—
+9K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+9K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+9K221104Actera™ hip systemConformis, Inc.202211
+10K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadSignature Orthopaedics Pty, Ltd.20260—
+10K252067Velora Acetabular SystemRestor3D, Inc.20250—
+10K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+10K243162World LinerSignature Orthopaedics Pty, Ltd.20240—
+10K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+10K231178ACTERA™ hip systemConformis, Inc.20230—