510(k) Report

Devices descending from K022599

118 later devices reach Newdeal K Wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203698CoLink Sfx Implant SystemIn2bones USA, LLC20211—
+1K153770OS2(R)-VP Varisation StapleIn2bones Sas20164—
+1K153204In2Bones Kirschner wireIn2bones Sas201620—
+1K150211EzFuze Implant SystemVilex IN Tennessee, Inc.20150—
+1K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemAscension Orthopedics20151—
+1K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+1K142490ProxiFuse Hammer Toe DeviceCartiva, Inc.20142—
+1K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc20149—
+1K141937Trident Fusion ImplantVilex IN Tennessee, Inc.20141—
+1K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+1K133477Toegrip, Implant for Proximal Inter-Phalangeal ArthrodesisSynchro Medical20149—
+1K132895WMT Implantable K-WireWrightmedicaltechnologyinc201327—
+1K120645Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc201261—
+1K120165Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.201235—
+1K103623Newdeal Interphalangeal ImplantNewdeal Sas20120—
+1K112675Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC201191
+1K111536Metasurg Digifuse ImplantMetasurg201130—
+1K110445Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC2011166
+1K102072Memometal Implants (K-Snap & TI-Fuse)Memometal Technologies20101—
+1K100926Arrowhead Fixation DeviceArrow Products, Inc.201010—
+1K101165Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc201080—
+1K070598Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-FuseMemometal Technologies200772—
+1K030336Kmedic External Fixation DevicesTeleflex Medical Group200316—
+2K233302OSSIOfiber® Compression StapleOSSIO, Ltd.20231—
+2K231905Electro-Spec Steri-CapsElectro-Spec, Inc.20230—
+2K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+2K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K211944Medline UNITE® Digital Fusion Screw SystemMedline Industries, Inc.20210—
+2K203475LimaCorporate Kirschner WireLima Corporate S.P.A.20210—
+2K200068Arthrex DynaNite K-WireArthrex, Inc.20200—
+2K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+2K191803Orthopedic Fixation PinTinavi (Anhui) Medical Technologies Co., Ltd.20200—
+2K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+2K190970PROSTEP™ TBI™ (Tailors Bunion Implant) SystemWrightmedicaltechnologyinc20191—
+2K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC20194—
+2K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+2K181898Two-Step Implant SystemTrilliant Surgical20180—
+2K172485Footmotion HammerToeNewclip Technics20180—
+2K173616DIP Arthrodesis SystemIn2bones Sas20180—
+2K170688PIT’Stop® implantIn2bones Sas20171—
+2K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+2K170326dynaMX Intramedullary ImplantArthrex, Inc.20172—
+2K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+2K163327Precifit Medical Kirschner WiresPrecifit Medical, Ltd.20170—
+2K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc.20170—
+2K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+2K160194StarFuse Interphalangeal PinPhalanx Innovations20160—
+2K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+2K151838PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc20154—
+2K142478opti-ToeGraham Medical Technologies, LLC (D.B.A.Gramedica)20151—
+2K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc20156—
+2K143049LYNC intramedullary implantNovastep20150—
+2K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+2K130019J-Screw Compression ScrewCompetitive Engineering, Inc.20140—
+2K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc20140—
+2K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+2K133844Speed TriadBiomedical Ent., Inc.20140—
+2K133515Peek Fusion ImplantMtp Solutions, LLC20142—
+2K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC201431—
+2K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc201420—
+2K140283Osteomed Extremifuse SystemOsteomed20140—
+2K131640Smooth or Threaded Metallic Bone FastenerBiomedical Ent., Inc.20137—
+2K130859Hammertoe Correction SystemArthrosurface, Inc.20134—
+2K130412Osteomed Extremifuse SystemOsteomed20134—
+2K122959Hammer Toe ImplantTrilliant Surgical, Ltd.2012221
+2K122031Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC20129—
+2K121008Trilliant Surgical K-WiresTrilliant Surgical, Ltd.201271
+2K112197Memometal Intra-Medullary Bone FastenerMemometal Technologies201151
+2K110047Verticor K-Wire SystemVerticor, Ltd.20110—
+2K102215Kirschner Wires, Steinman PinsEvergreen Orthopedic Research Lab20106—
+3K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+3K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+3K241932OSSIOfiber® Compression StapleOSSIO, Ltd.20240—
+3K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+3K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+3K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities20220—
+3K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+3K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+3K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20212—
+3K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc20210—
+3K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+3K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+3K201715Smart Toe II, X FuseStryker GmbH20201—
+3K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20203—
+3K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+3K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc.20191—
+3K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+3K183228HammerToe Compression SystemParagon 28, Inc.20190—
+3K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+3K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165—
+3K152710HammerFiX DeviceExtremity Medical, LLC20151—
+3K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+3K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+3K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC20140—
+3K140970One-Piece Peek Fusion ImplantMtp Solutions, LLC20140—
+3K133520Hammerlock 2Biomedical Enterprises, Inc.20145—
+3K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+4K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+4K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions20250—