510(k) Report

Devices descending from K960385

146 later devices reach Sterile Kirschner Wires and Steinmann Pins through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203605SteriTrakArbutus Medical, Inc.20210—
+1K173910Impress SFS SystemCable Fix Medical, LLC20180—
+1K181425APTUS® Proximal Humerus SystemMedartis AG20181—
+1K170326dynaMX Intramedullary ImplantArthrex, Inc.20172—
+1K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+1K111663Trauma Internal Fixation SystemsDePuy Orthopaedics, Inc.2012117
+1K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+1K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+1K102215Kirschner Wires, Steinman PinsEvergreen Orthopedic Research Lab20106—
+1K082017Starr Frame Steinmann PinStarr Frame, LLC20080—
+1K071035Ifs Bone Fixation DevicesInternal Fixation Systems, Inc.20073—
+1K070555Orthopro Steinman Pins and Kirschner WiresOrthopro, LLC200737—
+1K063589Gso Bone Fixation FastenersGold Standard Orthopaedics, LLC20074—
+1K061607Storm Operating Kit, Model 1-10-0Intelligent Orthopaedics, Ltd.20061—
+1K030336Kmedic External Fixation DevicesTeleflex Medical Group200316—
+1K022599Newdeal K WireNew Deal, S.A.2002118—
+1K012161Flex-NailsFixano SA20010—
+2K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—
+2K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+2K243761A.L.P.S. Small Fragment Plating SystemBiomet Orthopedics20250—
+2K203698CoLink Sfx Implant SystemIn2bones USA, LLC20211—
+2K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc.20191—
+2K181898Two-Step Implant SystemTrilliant Surgical20180—
+2K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+2K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+2K153770OS2(R)-VP Varisation StapleIn2bones Sas20164—
+2K153204In2Bones Kirschner wireIn2bones Sas201620—
+2K150211EzFuze Implant SystemVilex IN Tennessee, Inc.20150—
+2K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemAscension Orthopedics20151—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+2K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+2K150626Rush Medullary PinsZimmer, Inc.20150—
+2K142490ProxiFuse Hammer Toe DeviceCartiva, Inc.20142—
+2K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc20149—
+2K141937Trident Fusion ImplantVilex IN Tennessee, Inc.20141—
+2K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+2K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+2K133477Toegrip, Implant for Proximal Inter-Phalangeal ArthrodesisSynchro Medical20149—
+2K130613Cannulated Screw and Kirschner (Kwire) SystemLaura Cattabriga20141—
+2K132895WMT Implantable K-WireWrightmedicaltechnologyinc201327—
+2K121008Trilliant Surgical K-WiresTrilliant Surgical, Ltd.201271
+2K113006I-Fuse Hammer Toe SystemsOrthopro, LLC201227—
+2K120645Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc201261—
+2K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+2K120165Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.201235—
+2K103623Newdeal Interphalangeal ImplantNewdeal Sas20120—
+2K112675Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC201191
+2K111536Metasurg Digifuse ImplantMetasurg201130—
+2K111001Sterile Storm (R) Operating KitIntelligent Orthopaedics, Ltd.20110—
+2K110445Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC2011166
+2K110047Verticor K-Wire SystemVerticor, Ltd.20110—
+2K102072Memometal Implants (K-Snap & TI-Fuse)Memometal Technologies20101—
+2K100926Arrowhead Fixation DeviceArrow Products, Inc.201010—
+2K101165Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc201080—
+2K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies200772—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+3K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K231905Electro-Spec Steri-CapsElectro-Spec, Inc.20230—
+3K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+3K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+3K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+3K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+3K211944Medline UNITE® Digital Fusion Screw SystemMedline Industries, Inc.20210—
+3K203475LimaCorporate Kirschner WireLima Corporate S.P.A.20210—
+3K200068Arthrex DynaNite K-WireArthrex, Inc.20200—
+3K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+3K191803Orthopedic Fixation PinTinavi (Anhui) Medical Technologies Co., Ltd.20200—
+3K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+3K190970PROSTEP™ TBI™ (Tailors Bunion Implant) SystemWrightmedicaltechnologyinc20191—
+3K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC20194—
+3K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+3K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+3K172485Footmotion HammerToeNewclip Technics20180—
+3K173616DIP Arthrodesis SystemIn2bones Sas20180—
+3K170688PIT’Stop® implantIn2bones Sas20171—
+3K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+3K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+3K163327Precifit Medical Kirschner WiresPrecifit Medical, Ltd.20170—
+3K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc.20170—
+3K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+3K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165—
+3K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+3K160194StarFuse Interphalangeal PinPhalanx Innovations20160—
+3K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc.20161—
+3K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+3K151838PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc20154—
+3K142478opti-ToeGraham Medical Technologies, LLC (D.B.A.Gramedica)20151—
+3K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc20156—
+3K143049LYNC intramedullary implantNovastep20150—
+3K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+3K130019J-Screw Compression ScrewCompetitive Engineering, Inc.20140—
+3K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc20140—
+3K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+3K133844Speed TriadBiomedical Ent., Inc.20140—
+3K133515Peek Fusion ImplantMtp Solutions, LLC20142—
+3K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC201431—
+3K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc201420—