510(k) Report

Devices descending from K193038

8 later devices reach Comprehensive Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251098Identity Revision Humeral StemsZimmer, Inc.20250—
+1K214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemBiomet Manufacturing Corp20231—
+1K213856Identity Shoulder SystemZimmer, Inc.20224—
+1K212435Comprehensive Humeral Fracture Positioning SleevesBiomet, Inc.20210—
+2K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics20260—
+2K250848Identity Shoulder SystemZimmer, Inc.20250—
+2K240876Identity Shoulder SystemZimmer, Inc.20241—
+3K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…Zimmer, Inc.20260—