510(k) Report

Devices descending from K110415

13 later devices reach Signature Planner / Signature Guides through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173970Materialise PKA Guide SystemMaterialise NV20185—
+1K173445Materialise TKA Guide SystemMaterialise NV201891
+1K140257Signature Planner, Signature GuidesMaterialise NV20140—
+1K112301Zimmer Patient Specific Instruments PlannerMaterialise NV20127—
+2K221337Materialise TKA Guide SystemMaterialise NV202221
+2K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.20213—
+2K202207Materialise PKA Guide SystemMaterialise NV20200—
+2K172650Materialise PKA Guide SystemMaterialise NV20176—
+3K251554Materialise TKA Guide SystemMaterialise NV20251—
+3K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+4K253793Materialise TKA Guide SystemMaterialise NV20260—
+4K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+5K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—