510(k) Report

Devices descending from K052906

216 later devices reach Zimmer Trabecular Metal Reverse Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie20183—
+1K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+1K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+1K170711ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined SystemZimmer GmbH20172—
+1K133378Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201411—
+1K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+1K122692Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral StemsZimmer, Inc.201262—
+1K121543Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral StemsZimmer, Inc.201214—
+1K080642Comprehensive Reverse ShoulderBiomet, Inc.2008172Class I
+1K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007175—
+1K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200719013
+1K062029Anatomical Shoulder Fracture SystemZimmer GmbH2006103
+1K060704Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc.200620710
+2K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+2K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+2K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+2K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+2K233482Equinoxe® Central Screw Baseplate SystemExactech, Inc.20240—
+2K233148Augment Off-Axis Instrument SystemFix Surgical20242—
+2K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+2K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+2K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+2K232226ARROW Off-Centred Humeral InsertFH Industrie20230—
+2K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+2K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+2K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+2K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+2K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System…Stryker GmbH20210—
+2K210533Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20213—
+2K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+2K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+2K200368LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20213—
+2K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+2K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+2K193373Comprehensive® Reverse ShoulderBiomet, Inc.2020202
+2K192967Medacta Shoulder SystemMedacta International S.A.20200—
+2K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+2K193098Exactech® Equinoxe® Reverse Shoulder GlenospheresExactech, Inc.20200—
+2K193099Anatomical Shoulder SystemZimmer GmbH20201—
+2K191561Exactech Equinoxe Humeral Augmented TraysExactech, Inc.201901
+2K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+2K182536Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse…Exactech, Inc.201843
+2K181611Comprehensive Reverse Shoulder SystemBiomet Manufacturing Corp201810—
+2K180632Exactech Equinoxe Small Reverse Shoulder SystemExactech, Inc.201853
+2K172456Bone Screws 6.5mmLima Corporate S.P.A.201812
+2K172502Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…Biomet Manufacturing Corp2018201
+2K172767Zimmer Trabecular Metal Reverse Shoulder System, Mini GlenoidZimmer, Inc.20170—
+2K170452Medacta Shoulder SystemMedacta International S.A.201712—
+2K162325Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder…Exactech, Inc.20170—
+2K162726Exactech® Equinoxe® Preserve StemExactech, Inc.201731
+2K160085Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder…Zimmer GmbH20163—
+2K150568ARROW Humeral stems size 6 and 16Fournitures Hospitalieres Industrie20154—
+2K150458Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.20151—
+2K142403Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder…Zimmer GmbH201451
+2K130895Reunion Rsa Shoulder SystemHowmedica Osteonics Corp.201314—
+2K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+2K130390Comprehensive Convertible GlenoidBiomet Manufacturing, Inc.201381
+2K132239Comprehensive Reverse Shoulder ScrewsBiomet Manufacturing Corp2013252
+2K121183Comprehensive Reverse Shoulder - E1 Polyethylene ClaimsBiomet Corporation201214—
+2K112193Arrow Reverse Shoulder SystemFournitures Hospitalieres Industrie201210—
+2K120174Deput Delta Xtend Reverse ShoulderDepuy France2012412
+2K120121Comprehensive Reverse Shoulder-Mini BaseplateBiomet, Inc.2012694
+2K113069Comprehensive Reverse Shoulder Humeral TrayBiomet Manufacturing Corp201235—
+2K113121Comprehensive Reverse ShoulderBiomet Manufacturing, Inc.201131—
+2K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc.2011108—
+2K110708Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior…Exactech, Inc.201130—
+2K103404ANA0TOMICAL Shoulder TM Combined SystemZimmer GmbH201131
+2K102951Exactech Equinox Fixed Angle Replicator Plate (0MM,1.5MM,4.5MM), Humeral Head-Short…Exactech, Inc.201072
+2K093803Bio-Modular Reverse SholderBiomet Manufacturing Corp201061—
+2K093275Exactech Equinoxe Reverse Shoulder System 36MM Glenosphere and Humeral LinerExactech, Inc.2010313
+2K092900Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture StemExactech, Inc.201022
+2K082702Exactech Equinoxe Reverse Shoulder System+15MM Humeral Adapter TrayExactech, Inc.20084—
+2K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081771
+3K260556Veritas Shoulder SystemRestor3D20260—
+3K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K252516N22 EZ GlenosphereShoulder Innovations, Inc.20260—
+3K254003JARVIS Metaphyseal StemFH Industrie20260—
+3K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+3K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+3K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+3K252221Inset Reverse Total Shoulder SystemShoulder Innovations, Inc.20251—
+3K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+3K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+3K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+3K243643restor3d Reverse Total Shoulder Arthroplasty SystemRestor3D202511
+3K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+3K240876Identity Shoulder SystemZimmer, Inc.20241—
+3K241043Augment Off-Axis Instrument SystemFix Surgical202415
+3K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+3K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+3K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+3K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+3K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+3K213459Glenoid Reconstruction SystemMedacta International S.A.20225—
+3K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+3K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+3K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—