510(k) Report

Devices descending from K192163

6 later devices reach TTC Phantom® Intramedullary Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+2K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+2K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+3K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+3K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—