510(k) Report

Devices descending from K173970

5 later devices reach Materialise PKA Guide System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.20213—
+1K202207Materialise PKA Guide SystemMaterialise NV20200—
+2K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+3K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+4K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—