510(k) Report

Devices descending from K974044

440 later devices reach Global Total Shoulder Eccentric Humeral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042021Exactech Equinoxe Shoulder SystemExactech, Inc.20047110
+1K030710Bio-Modular Shoulder SystemBiomet, Inc.20032531
+1K992899Bio-Modular Shoulder Offset Humeral HeadsBiomet, Inc.1999254—
+1K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadDePuy Orthopaedics, Inc.1999405—
+2K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland)20220—
+2K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+2K191814Alliance GlenoidZimmer, Inc.20194—
+2K173388Exactech Equinoxe Stemless ShoulderExactech, Inc.20189—
+2K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+2K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+2K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+2K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+2K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+2K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+2K140390Titanium Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp20141—
+2K133834Depuy Global Unite Shoulder SystemDepuy (Ireland)2014211
+2K140063Equinoxe Extra Short Humeral HeadExactech, Inc.201410—
+2K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+2K131353Comprehensive Reverse Shoulder - Titanium GlenosphereBiomet Manufacturing Corp201360—
+2K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+2K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+2K111746Comprehensive Segmental Revision System (SRS)Biomet, Inc.201171
+2K113309Exactech Equinoxe Cage GlenoidsExactech, Inc.201138
+2K111097Humelock Cemented Shoulder ProsthesisFx Solutions2011342
+2K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110—
+2K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp.2011431
+2K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc.2010222
+2K093599Arrow Anatomical Shoulder SystemFournitures Hospitalieres Industrie201011—
+2K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+2K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc.2010241
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+2K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+2K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007191—
+2K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc.2007120—
+2K070565Cofield Total Shoulder SystemSmith & Nephew, Inc.200726—
+2K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20072508
+2K060694Modular Hybrid GlenoidBiomet Manufacturing Corp2006574
+2K060988Total and Hemi Shoulder SystemDvo Extremity Solutions, LLC200619413
+2K060874Depuy Global AP Shoulder SystemDePuy Orthopaedics, Inc.2006200—
+2K061454Exactech Equinoxe Shoulder StemsExactech, Inc.200616—
+2K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20061386
+2K060535Spacer-S Temporary Shoulder SpacerTecres S.P.A.20068—
+2K051843Copeland Eas Humeral Resurfacing HeadsBiomet, Inc.200561
+2K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc.20051761
+2K042321Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadBiomet Manufacturing Corp20059—
+2K042664LPS Upper ExtremityDepuy, Inc.20040—
+2K040610Versa-Dial Humeral HeadBiomet Manufacturing, Inc.200417—
+2K032895BI-Angular Shoulder SystemBiomet, Inc.200310—
+2K021478Delta ShoulderDepuy, Inc.2003338—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+3K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+3K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+3K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+3K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+3K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+3K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+3K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+3K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+3K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+3K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+3K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K193038Comprehensive Shoulder SystemBiomet Manufacturing Corp202081
+3K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+3K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K193180Alliance Augmented GlenoidZimmer, Inc.20203—
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+3K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+3K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+3K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+3K182516Comprehensive Nano Stemless ShoulderBiomet Manufacturing Corp20196—
+3K182799Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral HeadsArthrex, Inc.20190—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K173824Humeral Short Stem SystemShoulder Innovations, Inc.20183—
+3K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+3K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K173411Comprehensive Segmental Revision System (SRS)Biomet Manufacturing Corp20182—
+3K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+3K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+3K170452Medacta Shoulder SystemMedacta International S.A.201712—
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+3K153398Comprehensive SRS/Nexel ElbowBiomet Manufacturing Corp20163—
+3K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+3K143659Equinoxe Mega ProsthesisExactech, Inc.20155—
+3K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—