510(k) Report

Devices descending from K231112

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233408Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV20235—
+2K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV20244—
+3K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV20243—
+4K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder…Materialise NV20260—
+4K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.20260—
+4K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—