510(k) Report

Devices descending from K212569

11 later devices reach Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase… through their predicates, nearest generation first.

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