510(k) Report

Devices descending from K162455

17 later devices reach Humelock Reversed Shoulder through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20241—
+1K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20215—
+1K191146Humelock TiN Coated GlenosphereFx Shoulder USA, Inc.202001
+1K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+1K192799Glenoid Baseplate with ScrewFx Shoulder USA, Inc.20202—
+1K19220632mm Glenosphere and Humeral CupFx Shoulder USA, Inc.201941
+2K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie20250—
+2K234105Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc.20240—
+2K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+2K223655Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20230—
+2K221467INHANCETM Reverse Glenoid Peripheral PostsDepuy Ireland UC20220—
+2K210790Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20211—
+2K211991Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20213—
+3K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+3K243448Equinoxe® Shoulder SystemExactech, Inc.20250—
+3K240278Full Wedge Lateralized and Augmented BaseplatesFx Shoulder USA, Inc.20240—
+3K232583Catalyst R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc.20231—