510(k) Report

Devices descending from K190588

4 later devices reach Integra TITAN Reverse Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+1K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral…Smith & Nephew, Inc.20220—
+1K212992LINK® Embrace Shoulder System - Reverse ConfigurationWaldemar Link GmbH & Co. KG20210—
+2K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—