510(k) Report

Devices descending from K112982

11 later devices reach Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail ) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163589SIGN IM NailSign Fracture Care International20170—
+1K130147Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc.20139—
+2K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+3K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+3K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+5K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+5K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123