510(k) Report

Devices descending from K201227

5 later devices reach Phantom® Hindfoot TTC/TC Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+1K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+2K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+2K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+3K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—