510(k) Report

Devices descending from K192206

4 later devices reach 32mm Glenosphere and Humeral Cup through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193394Humeral Cup Stability & Humeral Cup 135/145o StabilityFx Shoulder USA, Inc.20203—
+2K223833Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.202321
+3K260583Equinoxe® Shoulder SystemExactech, Inc.20260—
+3K243448Equinoxe® Shoulder SystemExactech, Inc.20250—