510(k) Report

Devices descending from K050259

31 later devices reach Arthrex Bio-Pin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253325ZipToe™ Hammertoe Fusion SystemToetal Solutions20250—
+1K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+1K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+1K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+1K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+1K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC20164—
+1K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+1K151078Arthrex RetroFusion ScrewArthrex, Inc.20150—
+1K142490ProxiFuse Hammer Toe DeviceCartiva, Inc.20142—
+1K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+1K141577Arthrex Pip DartArthrex, Inc.20140—
+1K140970One-Piece Peek Fusion ImplantMtp Solutions, LLC20140—
+1K133515Peek Fusion ImplantMtp Solutions, LLC20142—
+1K122031Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC20129—
+1K110445Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC2011166
+1K071616Arc Surgical Biotrak Pin SystemArc Surgical, LLC20070—
+2K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+2K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+2K172485Footmotion HammerToeNewclip Technics20180—
+2K142478opti-ToeGraham Medical Technologies, LLC (D.B.A.Gramedica)20151—
+2K142528AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mmAgent Medical, LLC20140—
+2K130019J-Screw Compression ScrewCompetitive Engineering, Inc.20140—
+2K130859Hammertoe Correction SystemArthrosurface, Inc.20134—
+3K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+3K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+3K183228HammerToe Compression SystemParagon 28, Inc.20190—
+3K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc.20170—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+4K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+5K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—