510(k) Report

Devices descending from K190738

4 later devices reach MyShoulder Placement Guides through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243509Archer PSI System3D-Side20250—
+1K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+2K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+3K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—