510(k) Report

Devices descending from K081243

18 later devices reach Biomet Phoenix Ankle Nail System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+1K121575Oxford Ankle Fusion Nail (Afn) SystemOrtho Solutions Limited201211
+1K102577Force Medical IM Nail SystemForce Medical, Inc.20120—
+2K250622Succession™ AFN SystemOrtho Solutions UK, Ltd.20250—
+2K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+2K163589SIGN IM NailSign Fracture Care International20170—
+2K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+2K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+3K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+3K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+3K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+3K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+3K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+4K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+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