510(k) Report

Devices descending from K051678

16 later devices reach Synthes Hindfoot Arthrodesis Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182783DePuy Synthes Trauma Orthopedic Nail ImplantsDePuy Synthes20182—
+1K130051611 Ankle Fusion NailTornier S.A.S.20130—
+1K112982Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail )Small Bone Innovations, Inc.201211—
+2K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.20260—
+2K201830ANSER Clavicle PinBAAT Medical Products B.V.20200—
+2K163589SIGN IM NailSign Fracture Care International20170—
+2K130147Anatomic Ankle Arthrodesis Interlocking Nail (A3 Interlocking Nail)Small Bone Innovations, Inc.20139—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123