510(k) Report

Devices descending from K992119

419 later devices reach Bio-Modular Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+4K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+4K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+4K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+4K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.20250—
+4K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+4K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+4K251098Identity Revision Humeral StemsZimmer, Inc.20250—
+4K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+4K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+4K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K241470CORE Shoulder SystemLinkBio Corp.202501
+4K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+4K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+4K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+4K240876Identity Shoulder SystemZimmer, Inc.20241—
+4K241043Augment Off-Axis Instrument SystemFix Surgical202415
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.20230—
+4K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+4K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+4K223631Comprehensive Segmental Revision System (SRS)Biomet Orthopedics20231—
+4K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+4K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+4K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+4K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+4K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+4K213856Identity Shoulder SystemZimmer, Inc.20224—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K220792SMR Reverse LinerLima Corporate S.P.A.20227—
+4K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+4K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+4K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+4K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+4K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+4K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+4K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+4K192967Medacta Shoulder SystemMedacta International S.A.20200—
+4K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+4K193099Anatomical Shoulder SystemZimmer GmbH20201—
+4K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+4K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+4K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+4K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+4K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+4K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+4K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+4K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+4K171058Medacta Shoulder System: Threaded Glenoid BaseplateMedacta International S.A.20170—
+4K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+4K163669Humeris ShoulderFx Solutions201720—
+4K162903Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal BodiesExactech, Inc.20171—
+4K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+4K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+4K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+4K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+4K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+4K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+4K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+4K141006RSP Humeral Socket InsertDjo Global2014212
+4K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+4K133367Orthovis Preoperative PlanCustom Orthopaedic Solutions201323—
+4K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+4K132435Smith & Nephew Global Femoral Head TrialsSmith & Nephew, Inc.20130—
+4K131129Cas Psi ShoulderZimmer Cas201339—
+4K131575Exactech Equinox Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate - Left &…Exactech, Inc.20136—
+4K130642SMR 3-Pegs GlenoidsLima Corporate S.P.A.201314—
+4K121067Exactech Equinoxe Shoulder System Torque Defining Screw and Short Replicator PlateExactech, Inc.20120—
+4K121493Ascend Shoulder SystemTornier, Inc.201297—
+4K113523Limacorporate SMR Reverse Shoulder SystemLima Corporate S.P.A.201110—