510(k) Report

Devices descending from K063652

18 later devices reach Global AP Porous Coated Humeral Stem through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210—
+1K101996Depuy Global Unite Shoulder SystemDepuy (Ireland)2010168
+2K212710GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20210—
+2K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC20201—
+2K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC2018108
+2K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+3K250644MSS - Monobloc stemMedacta International S.A.202611
+3K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.20210—
+3K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+3K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+3K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland)20203—
+3K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+4K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+4K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+4K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC20260—
+4K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+4K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—
+4K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC20210—