510(k) Report

Devices descending from K122692

62 later devices reach Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral Stems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192967Medacta Shoulder SystemMedacta International S.A.20200—
+1K130048Reverse Shoulder Prosthesis MonoblockEncore Medical L.P.201359—
+1K130661Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc.201302
+2K141990Encore Humeral Shoulder StemEncore Medical L.P.2014193
+2K141006RSP Humeral Socket InsertDjo Global2014212
+2K140904RSP Monoblock Stem with P2 Coating, Size 6Encore Medical L.P.201455—
+3K251184AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA…Encore Medical L.P.20250—
+3K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+3K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.20200—
+3K190290AltiVate Reverse Humeral Stem, 48mmEncore Medical L.P.201915—
+3K183042SMR Lateralized Connectors with screwsLima Corporate S.P.A.20190—
+3K172351AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small…Encore Medical L.P.2017183
+3K162024AltiVate Anatomic Shoulder SystemEncore Medical L.P.2016346
+3K151293Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder ProsthesisTornier S.A.S.201520—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.20241—
+4K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K220847AETOS Shoulder SystemSmith & Nephew, Inc.20235—
+4K222317Catalyst EA Convertible Stemmed ShoulderCatalyst Orthoscience, Inc.20221—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K213387AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20221—
+4K213349Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20222—
+4K212800PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.202222
+4K202024ARROW Short Stem Humeral SystemFH Industrie20212—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K202716Ignite Anatomic Shoulder SystemIgnite Orthopedics, LLC202113—
+4K203026AltiVate® Anatomic Pegged Glenoid with MarkersEncore Medical L.P.20202—
+4K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+4K193226AltiVate Anatomic Canal-Sparing (CS) ShoulderEncore Medical L.P.20204—
+4K190521Aequalis Ascend Flex Shoulder SystemTornier S.A.S.201912—
+4K183077Delta Xtend Reverse Shoulder SystemDepuy (Ireland)20190—
+4K173073AltiVate Anatomic to Reverse Conversion ModuleEncore Medical L.P.20173—
+5K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc.20260—
+5K254003JARVIS Metaphyseal StemFH Industrie20260—
+5K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20250—
+5K253345JARVIS Diaphyseal Stem StandardFH Industrie20251—
+5K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc.20250—
+5K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20243—
+5K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+5K222592AltiVate® Anatomic Shoulder AG e+™ with MarkersEncore Medical L.P.20230—
+5K230572AETOS Shoulder SystemSmith & Nephew, Inc.20231—
+5K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+5K212933INHANCETM Hybrid Anatomic Glenoid ImplantDepuy Ireland UC20221—
+5K212737INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20229—
+5K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+5K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+5K201315PERFORM Humeral System – StemTornier, Inc.2020111
+6K260721Tornier Perform Advanced GlenoidTornier, Inc.20260—
+6K254128InSet Reverse Total Shoulder SystemShoulder Innovations, Inc.20260—
+6K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+6K250644MSS - Monobloc stemMedacta International S.A.202611
+6K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.20250—
+6K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+6K243248Inhance Intact™Depuy Ireland UC20240—
+6K241878Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…Stryker Corporation (Tornier, Inc.)20241—
+6K240876Identity Shoulder SystemZimmer, Inc.20241—
+6K220418Tornier Perform Humeral System – StemlessTornier, Inc.202201
+7K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—
+7K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+7K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—
+7K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.202501