510(k) Report

Devices descending from K130129

28 later devices reach Univers Revers Shoulder Prosthesis System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231445LINK Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20230—
+1K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc.20230—
+1K181555Arthrex Fracture Adapter Hemi Shoulder ProsthesisArthrex, Inc.20181—
+1K171841Arthrex Shoulder SystemArthrex, Inc.20181—
+1K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc.20164—
+1K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc.201427—
+2K221232Univers Revers Humeral Cup ImplantArthrex, Inc.20221—
+2K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.201817—
+2K172371Arthrex UNIVERS REVERS COATED BASEPLATEArthrex, Inc.20183—
+2K170414Arthrex Univers Revers Apex Humeral StemsArthrex, Inc.20171—
+3K252788Tornier Perform™ Reversed Monopost Glenoid (Perform Mono)Tornier, Inc.20260—
+3K212415Arthrex Modular Glenoid System-Titanium GlenosphereArthrex, Inc.20210—
+3K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+3K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc.202013—
+3K191960Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc.20190—
+3K182039Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid InlayArthrex, Inc.20180—
+4K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+4K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.20234—
+4K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+4K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+4K211074Univers Revers Modular Glenoid System, Standard Augment BaseplatesArthrex, Inc.20210—
+4K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+4K200895Univers Revers Modular Glenoid System, Half Augment BaseplateArthrex, Inc.20200—
+5K250644MSS - Monobloc stemMedacta International S.A.202611
+5K250338MSS - Humeral reverse liners extensionMedacta International S.A.20251—
+5K251737NextAR (TM) Shoulder PlatformMedacta International S.A.20250—
+5K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—
+6K261016MSS - Humeral reverse liners extensionMedacta International, SA20260—