510(k) Report

Devices descending from K242813

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

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