510(k) Report

Devices descending from K091425

31 later devices reach Quantum M Composite Nailing System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+1K131636Polarus ConnectAcumed, LLC20130—
+1K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+1K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+1K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+1K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+1K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+2K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+2K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+2K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+2K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+2K160995NEOVIEW Plating SystemIn2bones Sas201624
+2K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+2K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+2K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+2K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+2K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+2K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+3K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+3K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+3K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+3K163589SIGN IM NailSign Fracture Care International20170—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+4K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+5K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+5K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+5K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+6K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+6K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123