510(k) Report

Devices descending from K120645

61 later devices reach Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc.20170—
+1K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc20140—
+1K141937Trident Fusion ImplantVilex IN Tennessee, Inc.20141—
+1K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+1K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC201431—
+1K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc201420—
+1K132895WMT Implantable K-WireWrightmedicaltechnologyinc201327—
+2K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+2K203698CoLink Sfx Implant SystemIn2bones USA, LLC20211—
+2K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+2K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20203—
+2K200068Arthrex DynaNite K-WireArthrex, Inc.20200—
+2K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+2K190970PROSTEP™ TBI™ (Tailors Bunion Implant) SystemWrightmedicaltechnologyinc20191—
+2K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC20194—
+2K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+2K170326dynaMX Intramedullary ImplantArthrex, Inc.20172—
+2K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165—
+2K150211EzFuze Implant SystemVilex IN Tennessee, Inc.20150—
+2K152710HammerFiX DeviceExtremity Medical, LLC20151—
+2K151838PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc20154—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+2K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc20156—
+2K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+2K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc20149—
+2K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+3K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+3K231905Electro-Spec Steri-CapsElectro-Spec, Inc.20230—
+3K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20212—
+3K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc20210—
+3K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+3K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+3K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc.20191—
+3K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+3K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+3K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+3K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+3K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+3K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+4K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+4K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+4K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+4K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+5K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+5K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+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—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+7K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—