510(k) Report

Devices descending from K914695

451 later devices reach Global Total Shoulder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+4K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+4K120739Aequalis Adjustable Modular Reverse Shoulder SystemTornier, Inc.201212—
+4K121493Ascend Shoulder SystemTornier, Inc.201297—
+4K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+4K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+4K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+4K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+4K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+4K112983Spacer-STecres S.P.A.20117—
+4K111902Aequalis Shoulder SystemTornier201149—
+4K103251Duocentric ReversedAston Medical20117—
+4K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+4K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+4K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+4K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+4K103007Affiniti Total and Hemi-Shoulder SystemTornier, Inc.201071—
+4K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+4K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+4K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+4K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009159—
+4K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+4K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+4K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+4K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20081098
+4K073331Dvo Extended Articulation Humeral HeadsDvo Extremity Solutions, LLC20083—
+4K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc.2008161—
+4K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+4K063652Global AP Porous Coated Humeral StemDePuy Orthopaedics, Inc.200718—
+4K063081Aequalis Shoulder SystemTornier2006162—
+4K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006295—
+4K061439Aequalis Reversed ProsthesisTornier2006199—
+4K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+4K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH20062393
+4K050315Delta Humeral CupsDePuy Orthopaedics, Inc.2005196—
+4K050316Aequalis Reversed Shoulder ProsthesisTornier2005248—
+4K041873Aequalis Reversed Shoulder ProsthesisTornier2004277—
+4K030941Aequalis Reversed Shoulder ProsthesisTornier2004280—
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+5K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K250848Identity Shoulder SystemZimmer, Inc.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+5K241470CORE Shoulder SystemLinkBio Corp.202501
+5K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+5K241043Augment Off-Axis Instrument SystemFix Surgical202415
+5K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+5K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+5K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+5K223876SMR Shoulder SystemLima Corporate S.P.A.20233—
+5K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+5K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K222427PRIMA TT GlenoidLima Corporate S.P.A.202223
+5K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+5K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+5K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+5K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+5K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K202338SpaceFlex ShoulderG21, S.R.L.20211—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc.20200—
+5K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K192967Medacta Shoulder SystemMedacta International S.A.20200—
+5K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+5K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+5K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+5K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+5K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+5K181287Catalyst CSR Shoulder SystemCatalyst Orthoscience, Inc.20183—
+5K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.20180—
+5K173812Catalyst CSR 3 Peg GlenoidsCatalyst Orthoscience, Inc.20181—
+5K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+5K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+5K163669Humeris ShoulderFx Solutions201720—
+5K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+5K162455Humelock Reversed ShoulderFx Solutions201717—
+5K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+5K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+5K152966Aequalis Fx2Tornier S.A.S.201601
+5K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—