510(k) Report

Devices descending from K123810

14 later devices reach Piccolo Composite Ankle Arthrodesis Nailing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+1K163589SIGN IM NailSign Fracture Care International20170—
+1K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+1K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+2K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+2K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+2K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+2K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+2K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+3K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+3K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+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