510(k) Report

Devices descending from K920362

353 later devices reach 3M Modular Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+5K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+5K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+5K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+5K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+5K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+5K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K220914Tornier Perform Humeral System – FractureTornier, Inc.20222—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+5K212356Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.202221
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+5K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+5K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+5K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+5K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+5K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+5K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+5K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+5K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+5K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc.20200—
+5K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+5K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+5K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+5K192097Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.20201—
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+5K192967Medacta Shoulder SystemMedacta International S.A.20200—
+5K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+5K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+5K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+5K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+5K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+5K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+5K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+5K182500Catalyst CSR Press-Fit Humeral ComponentsCatalyst Orthoscience, Inc.20192—
+5K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+5K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+5K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+5K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+5K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+5K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+5K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+5K172210ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker Trauma AG201710—
+5K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie20174—
+5K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+5K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.2016533
+5K152825Catalyst CSR Shoulder SystemCatalyst Orthoscience, LLC20167—
+5K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+5K152966Aequalis Fx2Tornier S.A.S.201601
+5K152267Remedy® Shoulder SpacerOsteoremedies, LLC20152—
+5K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+5K150583Aequalis PerFORM+ Shoulder SystemTornier, Inc.201516—
+5K143374BLUEPRINT Patient Specific InstrumentationTornier S.A.S.201531—
+5K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+5K140478Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201421—
+5K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+5K141006RSP Humeral Socket InsertDjo Global2014212
+5K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+5K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+5K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+5K132285Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201326—
+5K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+5K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+5K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+5K131277Seviin Fracture ShoulderIngen Orthopedics, LLC20130—
+5K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+5K130129Univers Revers Shoulder Prosthesis SystemArthrex, Inc.201328—
+5K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+5K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+5K113413Ascend Shoulder SystemTornier, Inc.2012105—
+5K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+5K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+5K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+5K112983Spacer-STecres S.P.A.20117—
+5K103251Duocentric ReversedAston Medical20117—
+5K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+5K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc.2011212
+5K110865Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc.20110—
+5K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+5K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+5K101909Exactech Equinoxe, Platform Fracture StemExactech, Inc.201004
+5K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+5K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+5K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+5K071948Aequalis Reversed AdapterTornier2007178—
+6K260102Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…Stryker Corporation (Tornier, Inc.)20260—
+6K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+6K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+6K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+6K254003JARVIS Metaphyseal StemFH Industrie20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—