510(k) Report

Devices descending from K191641

3 later devices reach AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250498BPS Wrist Fracture SystemOrthonovis, Inc.20250—
+1K242343BPS Wrist Fracture SystemOrthonovis, Inc.20241—
+1K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—