510(k) Report

Devices descending from K062116

295 later devices reach Delta Cta Reverse Shoulder System Humeral Heads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+1K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+1K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+1K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20072508
+2K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+2K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+2K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+2K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+2K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+2K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+2K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+2K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+2K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+2K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+2K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+2K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+2K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+2K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+2K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+2K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic201356—
+2K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+2K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+2K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+2K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+2K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+2K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+2K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+2K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+2K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+2K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20081098
+2K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+2K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc.2008161—
+2K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007191—
+3K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+3K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+3K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+3K241470CORE Shoulder SystemLinkBio Corp.202501
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+3K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+3K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+3K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+3K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+3K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+3K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+3K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+3K193175Lateralized GlenosphereMedacta Inernational SA20201—
+3K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+3K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+3K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+3K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+3K162455Humelock Reversed ShoulderFx Solutions201717—
+3K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+3K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+3K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+3K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+3K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+3K141345Aequalis FX2Tornier S.A.S.201411
+3K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+3K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+3K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+3K131231Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier S.A.S.20135—
+3K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+3K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+3K131129Cas Psi ShoulderZimmer Cas201339—
+3K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+3K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+3K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+3K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+3K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+3K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+3K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+3K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+3K103251Duocentric ReversedAston Medical20117—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K103208Reverse Shoulder Prosthesis Monoblock StemEncore Medical L.P.201159—
+3K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+3K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+3K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+3K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009159—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—