510(k) Report

Devices descending from K070555

37 later devices reach Orthopro Steinman Pins and Kirschner Wires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131264Komet Medical Kirschner Wires, Steinmann Pins and Guide Pins and ScrewsGebr. Brasseler GmbH & Co. KG20131—
+1K113006I-Fuse Hammer Toe SystemsOrthopro, LLC201227—
+1K112254Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20115—
+1K102215Kirschner Wires, Steinman PinsEvergreen Orthopedic Research Lab20106—
+2K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLC20250—
+2K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+2K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+2K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+2K142585PhaLinx Hammertoe SystemWrightmedicaltechnologyinc20149—
+2K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+3K1626852-Piece Hammertoe Correction SystemLife Spine, Inc.20170—
+3K162032Arrowhead Mini-Rail FixatorArrowhead De, LLC20171—
+3K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+3K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+3K150252PHALINX Hammertoe SystemWrightmedicaltechnologyinc20156—
+4K252106External Fixation Mini Rail SystemParagon 28, Inc.20250—
+4K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyinc20210—
+4K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202032
+4K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+4K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+5K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+5K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+5K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+5K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.202112
+5K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.20210—
+5K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+6K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+6K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+6K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+6K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+6K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.20220—
+7K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+7K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+7K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+7K243658TMC Compression Implant SystemTreace Medical Concepts20242—