510(k) Report

Devices descending from K003718

54 later devices reach Titanium Cement Restrictor (TCR) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051607Novaspine Cement Restrictor NSCRNovaspine, LLC20050—
+1K022218Cadence Cement RestrictorSpinal Concepts, Inc.20024—
+1K012462Theken Large Cement RestrictorTheken Surgical,Llc20010—
+1K013014Block Cement Restrictor (CR) - TitaniumMedtronic Sofamor Danek, Inc.200147—
+1K011715Macropore IB Resorbable PlugMacropore Biosurgery, Inc.20010—
+1K012255Medtronic Sofamor Danek Cement RestrictorMedtronic Sofamor Danek, Inc.20017—
+2K031318Traxis Cement RestrictorSpinal Concepts, Inc.20031—
+2K023647Cadence Peek Cemeent RestrictorSpinal Concepts, Inc.20022—
+2K021719Fortitude Cement RestrictorSpinal Concepts, Inc.20026—
+2K020344RPX Titanium Cemnt RestrictorSulzer Spine-Tech200233—
+2K013663Cement RestrictorMedtronic Sofamor Danek, Inc.20018—
+3K060132Spinal Usa Cement Restrictor SystemSpinal USA20060—
+3K041583Peek Cement Restrictor X-BoxInnovasis, Inc.20040—
+3K030767Fidji Small Cement RestrictorSpine Next SA20030—
+3K031837Modification to Fortitude Cement RestrictorSpinal Concepts, Inc.20035—
+3K022729Vented Cement RestrictorAmedica Corp.20021—
+3K022615Centerpulse, Spine-Tech Division Cement RestrictorCenterpulse Spine-Tech, Inc.200232—
+3K020836Rabea Cement RestrictorSignus Medical, LLC20024—
+4K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd.201031—
+4K051371Interbody Innovations Cement RestrictorInterbody Innovations, Llp20050—
+4K052367Scient'x Cement RestrictorScient'X20051—
+4K050699Modification to: Vented Cement Restrictor, Model 60102-000-001/004Amedica Corp.20050—
+4K033953Optimesh 500E Cement RestrictorSpineology, Inc.20040—
+5K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+5K131636Polarus ConnectAcumed, LLC20130—
+5K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+5K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.2011151
+5K102597Piccolo Composite Plate SystemN.M.B. Medical Applications, Ltd.201115—
+5K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd.2011161
+5K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd.201029—
+6K201917Piccolo Composite Proximal Tibia Plate SystemCarboFix Orthopedics, Ltd.20200—
+6K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+6K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+6K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+6K160995NEOVIEW Plating SystemIn2bones Sas201624
+6K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+6K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+6K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+6K123810Piccolo Composite Ankle Arthrodesis Nailing SystemCarboFix Orthopedics, Ltd.201314—
+6K130061Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201310—
+6K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+7K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+7K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+7K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+7K163589SIGN IM NailSign Fracture Care International20170—
+8K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+8K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+8K192163TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20206—
+8K191782TTC Phantom Intramedullary Nail SystemParagon 28, Inc.20196—
+9K251850Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20251—
+9K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+9K201227Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20205—
+10K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.20260—
+10K210869Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.202123