510(k) Report

Devices descending from K210390

2 later devices reach Apex 3D Total Ankle Replacement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+2K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—