510(k) Report

Devices descending from K940537

281 later devices reach Kirschner (R) Modular II-C (TM) Total Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+5K260556Veritas Shoulder SystemRestor3D20260—
+5K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+5K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+5K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+5K250848Identity Shoulder SystemZimmer, Inc.20250—
+5K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+5K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+5K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+5K240876Identity Shoulder SystemZimmer, Inc.20241—
+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—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+5K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+5K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+5K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+5K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+5K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+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—
+5K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+5K203100Arthrex Eclipse Titanium Humeral HeadArthrex, Inc.20200—
+5K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+5K191698TiN Coated Humeral HeadFx Shoulder USA, Inc.20200—
+5K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+5K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+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
+5K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+5K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+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
+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—
+5K170452Medacta Shoulder SystemMedacta International S.A.201712—
+5K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A.2017121
+5K163669Humeris ShoulderFx Solutions201720—
+5K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+5K162455Humelock Reversed ShoulderFx Solutions201717—
+5K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+5K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K143256SMR Modular GlenoidLima Corporate S.P.A.20150—
+5K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+5K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+5K140390Titanium Versa-Dial Humeral Head ProsthesisBiomet Manufacturing Corp20141—
+5K140071Humelock II Cemented Shoulder SystemFx Solutions201431—
+5K141029Tornier Aequalis Adjustable Reverse Shoulder SystemTornier, Inc.20140—
+5K133349SMR TT Metal Back GlenoidLima Corporate S.P.A.201420—
+5K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+5K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+5K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+5K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+5K130050Titan Reverse Shoulder SystemAscension Orthopedic20139—
+5K131112Limacorporate SMR Cta Humeral HeadsLima Corporate S.P.A.20130—
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+5K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+5K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+5K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+5K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+5K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+5K112615Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.201197—
+5K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+5K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+5K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+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
+6K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+6K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+6K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+6K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+6K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+6K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K252443SpaceFix Shoulder SpacerG21, S.R.L.20250—
+6K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+6K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+6K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+6K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+6K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+6K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+6K241043Augment Off-Axis Instrument SystemFix Surgical202415
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—