510(k) Report

Devices descending from K981487

335 later devices reach Depuy Global Shoulder Glenoid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+4K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+4K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+4K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+4K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+4K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+5K262955OsseoFit Stemless Shoulder SystemZimmer, Inc.20260—
+5K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+5K253992Veritas Reverse Total Shoulder SystemRestor3D20260—
+5K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+5K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+5K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501
+5K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+5K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+5K250848Identity Shoulder SystemZimmer, Inc.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K243509Archer PSI System3D-Side20250—
+5K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+5K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+5K241043Augment Off-Axis Instrument SystemFix Surgical202415
+5K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+5K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+5K230904Arthrex Virtual Implant Positioning (VIP) SystemArthrex, Inc.20231—
+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—
+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
+5K212560Signature™ ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20217—
+5K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+5K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+5K210717Bone Screws dia. 5,0 mmLima Corporate S.P.A.20218—
+5K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+5K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20208—
+5K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+5K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+5K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+5K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+5K193099Anatomical Shoulder SystemZimmer GmbH20201—
+5K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+5K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+5K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas)20199—
+5K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+5K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20189—
+5K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K173372ExactechGPS Total Shoulder ApplicationBlue Ortho2017141
+5K163669Humeris ShoulderFx Solutions201720—
+5K162800BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201723—
+5K162455Humelock Reversed ShoulderFx Solutions201717—
+5K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K141345Aequalis FX2Tornier S.A.S.201411
+5K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+5K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+6K260556Veritas Shoulder SystemRestor3D20260—
+6K261683Augment Off-Axis Instrument SystemZimmer, Inc.20260—
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K243826SMR Reverse HP Shoulder SystemLima Corporate S.P.A.20251—
+6K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+6K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+6K241097Arthrex Virtual Implant Positioning (VIP) System SoftwareArthrex, Inc.20240—
+6K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+6K232425Signature™ ONE SystemOrthosoft Inc. (D/B/A) Zimmer Cas)20232—
+6K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K222510Blueprint Mixed Reality systemTornier S.A.S.2023010
+6K222936Humeris® 135 Shoulder SystemFx Shoulder USA, Inc.20220—
+6K222482AGILON XO Shoulder SystemImplantcast GmbH20223—
+6K213117FX V135 Shoulder ProsthesisFx Shoulder USA, Inc.20224—
+6K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho202281
+6K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+6K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K210153NextAR RSA PlatformMedacta International S.A.202151
+6K203315BLUEPRINT™ Patient Specific InstrumentationTornier S.A.S.202118—
+6K202232Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp20210—
+6K201315PERFORM Humeral System – StemTornier, Inc.2020111
+6K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+6K191247SmartSPACE Shoulder SystemTechmah Medical, LLC20193—
+6K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20198—
+6K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+6K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+6K152966Aequalis Fx2Tornier S.A.S.201601
+6K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+6K140082Aequalis (TM) Ascent (TM) Flex Shoulder SystemTornier S.A.S.201429—
+6K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+7K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.20260—