510(k) Report

Devices descending from K083439

18 later devices reach Synthes Epoca Shoulder Prosthesis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203108Ignite Stemless Anatomic Shoulder SystemIgnite Orthopedics, LLC20213—
+1K170452Medacta Shoulder SystemMedacta International S.A.201712—
+1K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A.201781
+2K250644MSS - Monobloc stemMedacta International S.A.202611
+2K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+2K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+2K243248Inhance Intact™Depuy Ireland UC20240—
+2K230831INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible GlenoidDepuy Ireland UC20230—
+2K223211INHANCETM Shoulder System – Humeral Stems and StemlessDepuy Ireland UC20220—
+2K210207Humeral Eccentric Reverse MetaphysisMedacta International S.A.20212—
+2K203755Shoulder System - TiNbN CoatingMedacta International S.A.20210—
+2K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH20203—
+2K193175Lateralized GlenosphereMedacta Inernational SA20201—
+2K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A.20183—
+3K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—
+3K260037implantcast Packaging System UpdateImplantcast GmbH20260—
+3K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH20251—
+3K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH20242—