510(k) Report

Devices descending from K193560

12 later devices reach Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+1K212569Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV202211—
+2K233992Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20242—
+2K220452Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder…Materialise NV20228—
+3K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20251—
+3K231112Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV20236—
+3K230315Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder…Materialise NV20230—
+4K233408Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV20235—
+5K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV20244—
+6K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV20243—
+7K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV20260—
+7K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—