510(k) Report

Devices descending from K050882

15 later devices reach Newdeal Ankle Nail through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited201211
+1K091788Panta Nail (Dia. 10MM), Panta Nail XLNewdeal Sas2009142
+2K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.20250—
+2K181639Panta 2 Arthrodesis Nail SystemIntegra LifeSciences Corporation20180—
+2K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas20181—
+2K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—
+2K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+2K102413Fuze: Intramedullary Internal Fixation NailVilex, Inc.201173
+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—