510(k) Report

Devices descending from K070598

72 later devices reach Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172485Footmotion HammerToeNewclip Technics20180—
+1K173616DIP Arthrodesis SystemIn2bones Sas20180—
+1K170326dynaMX Intramedullary ImplantArthrex, Inc.20172—
+1K150211EzFuze Implant SystemVilex IN Tennessee, Inc.20150—
+1K143049LYNC intramedullary implantNovastep20150—
+1K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc20140—
+1K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+1K133844Speed TriadBiomedical Ent., Inc.20140—
+1K133477Toegrip, Implant for Proximal Inter-Phalangeal ArthrodesisSynchro Medical20149—
+1K131640Smooth or Threaded Metallic Bone FastenerBiomedical Ent., Inc.20137—
+1K120165Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.201235—
+1K103623Newdeal Interphalangeal ImplantNewdeal Sas20120—
+1K112197Memometal Intra-Medullary Bone FastenerMemometal Technologies201151
+1K110445Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC2011166
+2K201715Smart Toe II, X FuseStryker GmbH20201—
+2K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+2K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc.20191—
+2K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+2K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+2K130019J-Screw Compression ScrewCompetitive Engineering, Inc.20140—
+2K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+2K133515Peek Fusion ImplantMtp Solutions, LLC20142—
+2K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC201431—
+2K133520Hammerlock 2Biomedical Enterprises, Inc.20145—
+2K130859Hammertoe Correction SystemArthrosurface, Inc.20134—
+2K122031Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC20129—
+3K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions20250—
+3K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+3K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+3K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+3K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+3K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+3K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20203—
+3K191463DePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLC202002
+3K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+3K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+3K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC20194—
+3K183228HammerToe Compression SystemParagon 28, Inc.20190—
+3K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+3K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc.20170—
+3K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165—
+3K152627IFS Fixation Scaffold SystemMetric Medical Devices, Inc.20160—
+3K152710HammerFiX DeviceExtremity Medical, LLC20151—
+3K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+3K142478opti-ToeGraham Medical Technologies, LLC (D.B.A.Gramedica)20151—
+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—
+4K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+4K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+4K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20212—
+4K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+4K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+4K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+4K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+5K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—