510(k) Report

Devices descending from K192365

2 later devices reach Shoulder Innovations Total Shoulder System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241817InSet Total Shoulder SystemShoulder Innovations, Inc.20251—
+2K262173N22 Offset Humeral HeadShoulder Innovations, Inc.20260—