510(k) Report

Devices descending from K950394

14 later devices reach Tibia-Talus-Calcaneus Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043052Trigen Hindfoot Fusion NailSmith & Nephew, Inc.2004137
+2K221221Advanced Intramedullary Nail SystemDouble Medical Technology, Inc.20220—
+2K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.202204
+2K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201
+2K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited201211
+2K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc.201173
+3K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.20250—
+3K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+4K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+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
+6K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+7K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—