510(k) Report

Devices descending from K172650

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173970Materialise PKA Guide SystemMaterialise NV20185—
+2K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.20213—
+2K202207Materialise PKA Guide SystemMaterialise NV20200—
+3K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+4K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+5K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—