510(k) Report

Devices descending from K133636

31 later devices reach Extremity Medical Hammertoe Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+1K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20203—
+1K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+1K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC20194—
+1K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165—
+1K152710HammerFiX DeviceExtremity Medical, LLC20151—
+1K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+1K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+1K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+2K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20212—
+2K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+2K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+2K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+2K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+3K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+3K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+4K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+4K250613SnapHammer Hammertoe Correction 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—
+4K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+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—
+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—