510(k) Report

Devices descending from K161189

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

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