510(k) Report

Devices descending from K110445

16 later devices reach Flexfusion (TM) Fixation Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+1K130019J-Screw Compression ScrewCompetitive Engineering, Inc.20140—
+1K133515Peek Fusion ImplantMtp Solutions, LLC20142—
+1K130859Hammertoe Correction SystemArthrosurface, Inc.20134—
+1K122031Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC20129—
+2K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+2K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+2K183228HammerToe Compression SystemParagon 28, Inc.20190—
+2K172485Footmotion HammerToeNewclip Technics20180—
+2K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+2K170350ToeMATE® Hammertoe Correction SystemArthrosurface, Inc.20170—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+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—
+2K140970One-Piece Peek Fusion ImplantMtp Solutions, LLC20140—
+3K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—