510(k) Report

Devices descending from K150928

12 later devices reach Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162273Materialise TKA Guide SystemMaterialise NV201611—
+2K173445Materialise TKA Guide SystemMaterialise NV201891
+2K172650Materialise PKA Guide SystemMaterialise NV20176—
+3K221337Materialise TKA Guide SystemMaterialise NV202221
+3K173970Materialise PKA Guide SystemMaterialise NV20185—
+4K251554Materialise TKA Guide SystemMaterialise NV20251—
+4K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.20213—
+4K202207Materialise PKA Guide SystemMaterialise NV20200—
+5K253793Materialise TKA Guide SystemMaterialise NV20260—
+5K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+6K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+7K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—