510(k) Report

Devices descending from K030665

113 later devices reach Bone Wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131459Aap K-Wire, Steinmann Pin, Cerclage WireAap Implantate AG201312—
+1K100736Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH201065—
+1K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+2K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+2K231339Tyber Medical Pin and Wire System (various)Tyber Medical, LLC20230—
+2K213982Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide WiresPacific Instruments20220—
+2K203811GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited20220—
+2K192768Temporary Fixation PinsEisertech, LLC20191—
+2K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+2K182171SMV Scientific K-Wire and PinsSummit Medventures20181—
+2K180348Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.20183—
+2K171715HammerTube SystemParagon 28201861
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K142134C-Wire Double Ended Orthopedic WiresConmed Corporation, Largo20140—
+2K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+2K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+2K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+2K120787Merete Locking Bone Plate System IiiMerete Medical GmbH201212—
+2K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG201224—
+2K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+2K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+2K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+2K102528N-Force Fixation SystemInnovision, Inc.20115—
+2K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+2K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+2K110047Verticor K-Wire SystemVerticor, Ltd.20110—
+2K102072Memometal Implants (K-Snap & TI-Fuse)Memometal Technologies20101—
+2K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+3K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.20260—
+3K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+3K250315Ronavis – FX (FX-001)AIRS, Inc.20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K241695Extremity All Suture SystemField Orthopaedics20240—
+3K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+3K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts20234—
+3K231905Electro-Spec Steri-CapsElectro-Spec, Inc.20230—
+3K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+3K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20226—
+3K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+3K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K183228HammerToe Compression SystemParagon 28, Inc.20190—
+3K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+3K173693Orbitum Bone Staple Implant, X and VIOrthovestments, LLC20180—
+3K172205ExoToe StapleExotoe, LLC20180—
+3K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+3K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+3K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+3K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+3K151160Arcus Staple SystemNextremity Solutions, Inc.20151—
+3K151146N-Force Fixation SystemInnovision, Inc.20151—
+3K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+3K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+3K150626Rush Medullary PinsZimmer, Inc.20150—
+3K142776Flow-ScrewFlow-Fx, LLC20151—
+3K143049LYNC intramedullary implantNovastep20150—
+3K132244N-Force Fixation SystemInnovision, Inc.20143—
+3K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+3K131061Restore Bunion Correction SystemNextremity Solutions201315—
+3K130627Swing-Off ScrewAdvanced Interventional Technology, LLC20130—
+3K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+3K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+4K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+4K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+4K241262Baby Gorilla/Gorilla Plating System; Monster Screw SystemParagon 28, Inc.20240—
+4K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K210658Volition Plating SystemOrtho Solutions UK, Ltd.20210—
+4K210456Ligament StapleMedacta International S.A.20210—
+4K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+4K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC202132
+4K202764Ortho Solutions Plating SystemOrtho Solutions UK, Ltd.20201—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+4K163593Additive Orthopaedics Bunion SystemAdditive Orthopaedics, LLC20170—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+4K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+4K152548AXI+LINE Proximal Bunion Correction SystemNextremity Solutions, Inc.20150—
+5K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+5K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+5K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+5K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+5K241387CoLink NeoFuse MIS Plating System (see attached parts list)In2bones USA20240—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+5K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+5K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower20220—
+5K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+5K212297Omni Foot and Ankle Plating SystemExtremity Medical, LLC20211—