510(k) Report

Devices descending from K091788

14 later devices reach Panta Nail (Dia. 10MM), Panta Nail XL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181639Panta 2 Arthrodesis Nail SystemIntegra LifeSciences Corporation20180—
+1K173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemIn2bones Sas20181—
+1K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie20150—
+1K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie20150—
+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—