510(k) Report

Devices descending from K113829

13 later devices reach Zimmer Patient Specific Instrument System Zimmer Patient Specific Instruments… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140027Zimmer Patient Specific Instruments/ System/PlannerMaterialise NV201412—
+2K193312UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20201—
+2K173445Materialise TKA Guide SystemMaterialise NV201891
+3K240327UNIKO PointCloud™ Knee InstrumentsUnik Orthopedics, Inc.20240—
+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—