510(k) Report

Devices descending from K790987

271 later devices reach Zimmer R Total Shoulder II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+5K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+5K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+5K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+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—
+5K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+5K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+5K202338SpaceFlex ShoulderG21, S.R.L.20211—
+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—
+5K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+5K192967Medacta Shoulder SystemMedacta International S.A.20200—
+5K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+5K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+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—
+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—
+5K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+5K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+5K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc.201635
+5K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+5K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+5K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie20155—
+5K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+5K131135Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet Manufacturing Corp201445
+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
+5K122698Aequalis Ascend Flex Shoulder SystemTornier S.A.S.2013962
+5K121220Equinoxe Glenoid, Uhmwpe 16 PS=Osterior Augment Pegged, Small, Left/RightExactech, Inc.2012202
+5K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+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—
+5K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+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
+6K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+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—
+6K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+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—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K241043Augment Off-Axis Instrument SystemFix Surgical202415
+6K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+6K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+6K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+6K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+6K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+6K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+6K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.20220—
+6K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+6K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+6K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K211729Comprehensive® Convertible Glenoid - Vivacit-E LinerBiomet Manufacturing Corp20212—
+6K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+6K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—
+6K210899LINK Embrace Shoulder System- Anatomical ConfigurationWaldemar Link GmbH & Co. KG20210—
+6K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+6K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+6K210167DELTA XTEND Reverse Shoulder SystemDePuy Orthopaedics, Inc.20210—
+6K200171SMR TT Augmented Glenoid SystemLima Corporate S.P.A.202011—
+6K193175Lateralized GlenosphereMedacta Inernational SA20201—
+6K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+6K191746SMR TT Augmented Glenoid SystemLima Corporate S.P.A.201912—
+6K191963SMR Finned Short StemsLima Corporate S.P.A.201913—
+6K192448Delta Xtend Revers Shoulder SystemDepuy (Ireland)20191—
+6K191811Catalyst OrthoScience CSR Shoulder SystemCatalyst Orthoscience, Inc.20190—
+6K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+6K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+6K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+6K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+6K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+6K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+6K163669Humeris ShoulderFx Solutions201720—
+6K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty (RSA)…Stryker GmbH201613—
+6K161620Anatomical Shoulder Domelock Dome centricZimmer GmbH20163—
+6K152754Comprehensive Vault Reconstruction System (VRS)Biomet Manufacturing Corp2016221
+6K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—