510(k) Report

Devices descending from K130050

9 later devices reach Titan Reverse Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161189Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20168—
+2K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+2K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+2K190588Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20194—
+2K173717Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20183—
+3K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+3K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+3K181999Integra TITAN Reverse Shoulder SystemIntegra LifeSciences Corporation20182—
+4K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—