510(k) Report

Devices descending from K140027

12 later devices reach Zimmer Patient Specific Instruments/ System/Planner through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193312UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20201—
+1K173445Materialise TKA Guide SystemMaterialise NV201891
+2K240327UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20240—
+2K221337Materialise TKA Guide SystemMaterialise NV202221
+2K173970Materialise PKA Guide SystemMaterialise NV20185—
+3K251554Materialise TKA Guide SystemMaterialise NV20251—
+3K211512VISIONAIRE UK Patient Matched Cutting GuidesSmith & Nephew, Inc.20213—
+3K202207Materialise PKA Guide SystemMaterialise NV20200—
+4K253793Materialise TKA Guide SystemMaterialise NV20260—
+4K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.20242—
+5K242272CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20241—
+6K250921CORIOGRAPH Pre-Op Planning and Modeling ServicesBlue Belt Technologies, Inc.20250—