510(k) Report

Devices descending from K111536

30 later devices reach Metasurg Digifuse Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150211EzFuze Implant SystemVilex IN Tennessee, Inc.20150—
+1K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemAscension Orthopedics20151—
+1K141937Trident Fusion ImplantVilex IN Tennessee, Inc.20141—
+1K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas201422
+1K140283Osteomed Extremifuse SystemOsteomed20140—
+1K122959Hammer Toe ImplantTrilliant Surgical, Ltd.2012221
+2K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.20220—
+2K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+2K181898Two-Step Implant SystemTrilliant Surgical20180—
+2K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+2K140148Pro-Toe Hammertoe Fixation SystemWrightmedicaltechnologyinc201420—
+3K170326dynaMX Intramedullary ImplantArthrex, Inc.20172—
+3K151838PRO-TOE Hammertoe Fixation SystemWrightmedicaltechnologyinc20154—
+3K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc20156—
+3K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc20149—
+3K141714Pro-Toe X-Flex Hammertoe Fixation SystemWrightmedicaltechnologyinc20140—
+4K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc20210—
+4K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+4K190926Hammertoe Truss System (HTS)4Web, Inc.20193—
+4K190287Arthrex DynaNite® PIP (Hammertoe) ImplantArthrex, Inc.20191—
+4K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+4K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+4K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+5K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+5K221283Hammertoe Truss System (HTS)4Web Medical, Inc.20222—
+5K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+5K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+6K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+6K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+7K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—