510(k) Report

Devices descending from K083912

48 later devices reach Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+1K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+1K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+1K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+1K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+1K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+1K102528N-Force Fixation SystemInnovision, Inc.20115—
+1K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+1K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+1K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+2K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+2K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+2K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+2K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+2K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+2K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+2K151146N-Force Fixation SystemInnovision, Inc.20151—
+2K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+2K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+2K150626Rush Medullary PinsZimmer, Inc.20150—
+2K142776Flow-ScrewFlow-Fx, LLC20151—
+2K132244N-Force Fixation SystemInnovision, Inc.20143—
+2K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+2K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+3K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+3K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+3K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+3K173556Injection ScrewBiedermann Medtech, Inc.20180—
+3K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+3K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+4K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+4K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+4K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+4K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20211—
+5K252961Fusion FibFix NailFusion Orthopedics USA, LLC20260—