510(k) Report

Devices descending from K162841

4 later devices reach VariAx Distal Radius Plating System, VariAx 2 System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius…Industrias Medicas Sampedro S.A.S20193—
+2K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+2K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+2K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—