510(k) Report

Devices descending from K961522

439 later devices reach Kirschner Wire (K-Wire) and Steinmann Pin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+1K030665Bone WireStork Instrumente GmbH2003113—
+1K990156Multitak SS ButtonsBonutti Research1999336—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+2K150626Rush Medullary PinsZimmer, Inc.20150—
+2K131459Aap K-Wire, Steinmann Pin, Cerclage WireAap Implantate AG201312—
+2K100736Kirschner and Guide WiresSmt Schilling Metalltechnik GmbH201065—
+2K083912Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen PinsTreu-Instrumente GmbH200948—
+2K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004309—
+2K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031611
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K231339Tyber Medical Pin and Wire System (various)Tyber Medical, LLC20230—
+3K213982Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide WiresPacific Instruments20220—
+3K203811GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited20220—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K192768Temporary Fixation PinsEisertech, LLC20191—
+3K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+3K182171SMV Scientific K-Wire and PinsSummit Medventures20181—
+3K180348Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.20183—
+3K171715HammerTube SystemParagon 28201861
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+3K142134C-Wire Double Ended Orthopedic WiresConmed Corporation, Largo20140—
+3K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc.20145—
+3K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+3K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+3K123341Arthrex Pec Repair Button, Arthrex Large Pec Button, Arthrex Biceps Button, Arthrex…Arthrex, Inc.201252—
+3K120787Merete Locking Bone Plate System IiiMerete Medical GmbH201212—
+3K121277Z-Snap Off Screw, Z-Double Thread Compression Screw, Z-Guide Wire, Z-StapleZ-Medical GmbH & Co. KG201224—
+3K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets20129—
+3K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+3K102528N-Force Fixation SystemInnovision, Inc.20115—
+3K102845Mahe Fixation Plate and Screw SystemMahe Medical GmbH20118—
+3K101338Newfix External Fixation SystemTechnologia Y Diseno Industrial, S.A DE C.V20110—
+3K110047Verticor K-Wire SystemVerticor, Ltd.20110—
+3K102072Memometal Implants (K-Snap & TI-Fuse)Memometal Technologies20101—
+3K101254Newfix Screw, Wire and Pin Fixarion SystemTecnologia Y Diseno Industrial, S.A DE C.V20101—
+3K100652Acl TightropeArthrex, Inc.201065—
+3K090107Mini TightropeArthrex, Inc.200921—
+3K081348Tenodesis Cross Screw, Interference Screw, Suture BeadTriMed, Inc.20081—
+3K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006143—
+3K052901Arthrex TensionlokArthrex, Inc.20050—
+3K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc.2005306—
+4K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.20260—
+4K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc.20260—
+4K252081SportLinc Syndesmosis DeviceLincotek Medical20260—
+4K253727Syndesmosis TightRope PROArthrex, Inc.20250—
+4K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+4K250315Ronavis – FX (FX-001)AIRS, Inc.20250—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K241995HyperFlex™ Bunion Correction SystemFootbridge Medical20241—
+4K242311EXPERT - Flexible Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20240—
+4K241695Extremity All Suture SystemField Orthopaedics20240—
+4K232941Megaloop Button SystemSuzhou Endophix Co., Ltd.20240—
+4K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation…Paragon 28, Inc.20231—
+4K232387Treace Medical Concepts (TMC) Compression Implant SystemTreace Medical Concepts20234—
+4K231905Electro-Spec Steri-CapsElectro-Spec, Inc.20230—
+4K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.20220—
+4K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+4K222645Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20226—
+4K220260Hercules Syndesmosis Implant SystemIn2bones USA, LLC20220—
+4K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+4K213644Arthrex Knotless Mini TightRopesArthrex, Inc.20211—
+4K211049Tigon Medical Button SystemTigon Medical20210—
+4K203121Responsive Arthroscopy Thunderbolt SystemResponsive Arthroscopy, LLC20211—
+4K202444Knotless TensionTight Button Implant SystemArthrex, Inc.20201—
+4K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+4K200332EXPERT - Joint Fixation SystemGM Dos Reis Industria e Comercio Ltda.20201—
+4K201522Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc.20207—
+4K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+4K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+4K191426FiberTak ButtonArthrex, Inc.20190—
+4K191783Parcus Synd-EZ TiParcus Medical, LLC20195—
+4K190288Arthrex Tenodesis ButtonArthrex, Inc.20194—
+4K191319Dunamis Fixation Button SystemDunamis, LLC20191—
+4K190774RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL ImplantMedos International SARL20191—
+4K183228HammerToe Compression SystemParagon 28, Inc.20190—
+4K181086Cortical Fixation SystemsCousin Biotech Sas20190—
+4K173910Impress SFS SystemCable Fix Medical, LLC20180—
+4K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+4K171703PUMA SystemPanther Orthopedics, Inc.20180—
+4K173693Orbitum Bone Staple Implant, X and VIOrthovestments, LLC20180—
+4K172205ExoToe StapleExotoe, LLC20180—
+4K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical20174—
+4K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC20170—
+4K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+4K170388ANCHORMAN Tibial Ligament Fixation DeviceSummit Medical, Ltd.20170—
+4K170249GRAVITY™ Syndesmosis LPWrightmedicaltechnologyinc20172—
+4K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+4K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+4K162805Akros Fibulink Syndesmosis Repair KitAkros Medical20175—
+4K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+4K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+4K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete…Merete Medical GmbH20160—
+4K151160Arcus Staple SystemNextremity Solutions, Inc.20151—
+4K150768JuggerKnot Soft AnchorsBiomet Manufacturing Corp201540—
+4K151146N-Force Fixation SystemInnovision, Inc.20151—
+4K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—