510(k) Report

Devices descending from K021478

338 later devices reach Delta Shoulder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+3K241470CORE Shoulder SystemLinkBio Corp.202501
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+3K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+3K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+3K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+3K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+3K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+3K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+3K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+3K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+3K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+3K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+3K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+3K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+3K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+3K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+3K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+3K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+3K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+3K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+3K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+3K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+3K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+3K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+3K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+3K192967Medacta Shoulder SystemMedacta International S.A.20200—
+3K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+3K193099Anatomical Shoulder SystemZimmer GmbH20201—
+3K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+3K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+3K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+3K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+3K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+3K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+3K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+3K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+3K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+3K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+3K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+3K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+3K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+3K163669Humeris ShoulderFx Solutions201720—
+3K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+3K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+3K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+3K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+3K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+3K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A.201613—
+3K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+3K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+3K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+3K141006RSP Humeral Socket InsertDjo Global2014212
+3K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+3K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+3K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+3K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+3K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+3K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+3K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+3K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+3K131129Cas Psi ShoulderZimmer Cas201339—
+3K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+3K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+3K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+3K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+3K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A.201231—
+3K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+3K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+3K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—
+3K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+3K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+3K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+3K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+3K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+4K260556Veritas Shoulder SystemRestor3D20260—
+4K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+4K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+4K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+4K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+4K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K233481AltiVate Reverse® GlenoidEncore Medical L.P.202448
+4K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—