510(k) Report

Devices descending from K101996

16 later devices reach Depuy Global Unite Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+1K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+1K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+1K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+2K250644MSS - Monobloc stemMedacta International S.A.202611
+2K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+2K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+2K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+2K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+2K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+3K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+3K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+3K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—