510(k) Report

Devices descending from K043052

13 later devices reach Trigen Hindfoot Fusion Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221221Advanced Intramedullary Nail SystemDouble Medical Technology, Inc.20220—
+1K210980Smith & Nephew Intramedullary Nail SystemsSmith & Nephew, Inc.202204
+1K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc.201201
+1K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited201211
+1K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc.201173
+2K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.20250—
+2K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+3K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+3K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+4K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+4K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—