510(k) Report

Devices descending from K022615

32 later devices reach Centerpulse, Spine-Tech Division Cement Restrictor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+2K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+2K131636Polarus ConnectAcumed, LLC20130—
+2K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+2K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+2K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+2K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+2K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+3K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K160995NEOVIEW Plating SystemIn2bones Sas201624
+3K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+3K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+3K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+3K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+3K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+3K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K163589SIGN IM NailSign Fracture Care International20170—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+5K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+5K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+6K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+6K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+6K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+7K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+7K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123