510(k) Report

Devices descending from K984541

425 later devices reach Global FX Humeral Stem, Global Advantage Humeral Head through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K120794Ascend Shoulder SystemTornier, Inc.201298—
+3K112144Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis…Tornier201223—
+3K112983Spacer-STecres S.P.A.20117—
+3K111902Aequalis Shoulder SystemTornier201149—
+3K103251Duocentric ReversedAston Medical20117—
+3K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+3K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+3K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.2011110—
+3K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+3K103007Affiniti Total and Hemi-Shoulder SystemTornier, Inc.201071—
+3K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+3K100142Aequalis Reversed Shoulder ProsthesisTornier2010147—
+3K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc.2009159—
+3K082120Aequalis Reversed Fracture Shoulder ProthesisTornier2008164—
+3K081016Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc.2008522
+3K081707Aequalis Shoulder Fracture and Shoulder SystemsTornier, Inc.200825—
+3K081620Modification to Depuy Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20081098
+3K073331Dvo Extended Articulation Humeral HeadsDvo Extremity Solutions, LLC20083—
+3K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc.2008161—
+3K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+3K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+3K063652Global AP Porous Coated Humeral StemDePuy Orthopaedics, Inc.200718—
+3K063081Aequalis Shoulder SystemTornier2006162—
+3K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006295—
+3K061439Aequalis Reversed ProsthesisTornier2006199—
+3K060716Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp200616—
+3K053274Anatomical Shoulder Inverse/ReverseZimmer GmbH20062393
+3K052906Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.200521612
+3K050315Delta Humeral CupsDePuy Orthopaedics, Inc.2005196—
+3K050316Aequalis Reversed Shoulder ProsthesisTornier2005248—
+3K041873Aequalis Reversed Shoulder ProsthesisTornier2004277—
+3K030941Aequalis Reversed Shoulder ProsthesisTornier2004280—
+4K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+4K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+4K260556Veritas Shoulder SystemRestor3D20260—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+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—
+4K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+4K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+4K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+4K251098Identity Revision Humeral StemsZimmer, Inc.20250—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K241470CORE Shoulder SystemLinkBio Corp.202501
+4K243248Inhance Intact™Depuy Ireland UC20240—
+4K241873OsseoFit Stemless Shoulder SystemZimmer, Inc.20241—
+4K240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbH20240—
+4K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.20230—
+4K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+4K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc.20230—
+4K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+4K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+4K213856Identity Shoulder SystemZimmer, Inc.20224—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+4K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidLimacorporate20220—
+4K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+4K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+4K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+4K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+4K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+4K202338SpaceFlex ShoulderG21, S.R.L.20211—
+4K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+4K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+4K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+4K193175Lateralized GlenosphereMedacta Inernational SA20201—
+4K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+4K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+4K192365Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.20192—
+4K190911Physica KR Liner and SMR Reverse Humeral LinerLimacorporate20198—
+4K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+4K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+4K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+4K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+4K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+4K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+4K163669Humeris ShoulderFx Solutions201720—
+4K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+4K161120SMR TT Metal Back Glenoid, Bone Graft instrumentsLima Corporate S.P.A.20172—
+4K162455Humelock Reversed ShoulderFx Solutions201717—
+4K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+4K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+4K152966Aequalis Fx2Tornier S.A.S.201601
+4K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc.20152—
+4K150488Humelock II Reversible Shoulder SystemFx Solutions201530—
+4K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+4K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+4K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+4K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+4K143552Simpliciti Shoulder SystemTornier, Inc.201524—
+4K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+4K142072Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Custom Orthopaedic Solutions, Inc.201410—
+4K141345Aequalis FX2Tornier S.A.S.201411