510(k) Report

Devices descending from K113006

27 later devices reach I-Fuse Hammer Toe Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+1K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc20149—
+2K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+2K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+2K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+2K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc20156—
+3K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc20210—
+3K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+3K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+3K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+4K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+4K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+4K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+4K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+4K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+4K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+5K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+5K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+5K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+6K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+6K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+6K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+6K243658TMC Compression Implant SystemTreace Medical Concepts20242—