510(k) Report

Devices descending from K102413

7 later devices reach Fuze: Intramedullary Internal Fixation Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+2K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+2K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+3K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+3K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—