510(k) Report

Devices descending from K050275

51 later devices reach Modification to: Inion Otps Biodegradable Pin through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181180OSSIO™ Pin Product FamilyOSSIO, Ltd.201913—
+1K133932Inion FreedompinInion OY20144—
+1K061164ActivapinBioretec, Ltd.200637—
+2K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies20253—
+2K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…OSSIO, Ltd.20233—
+2K211789restor3d Pin ImplantsRestor3D20220—
+2K203465OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail…OSSIO, Ltd.20215—
+2K190652OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOSSIO, Ltd.20201—
+2K141004Intraosseous Fixation SystemOrthohelix Surgical Designs, Inc.20140—
+2K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC201431—
+2K133950Activapin HT, Fuse Link (Private Labled for Footmind, Inc.)Bioretec, Ltd.20140—
+2K080879Activatm Product Group Including Bioabsorbable Devices Activapin Fusion, Activanailtm…Bioretec, Ltd.20081—
+2K071863Activapin, Nexfix RFS Pin, Nexfix Resorbable Fixation System (RFS)Bioretec, Ltd.20070—
+2K062980ActivascrewBioretec, Ltd.20061—
+3K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+3K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+3K252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.20250—
+3K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+3K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+3K230750OSSIOfiber® Cannulated Trimmable Fixation NailOSSIO, Ltd.20234—
+3K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.20200—
+3K201803OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation ImplantOSSIO, Ltd.20200—
+3K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20203—
+3K191424Interphalangeal Joint Fusion Device RangeNeosteo20190—
+3K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC20194—
+3K161449HammerTech Fixation SystemFusion Orthopedics, LLC20165—
+3K152710HammerFiX DeviceExtremity Medical, LLC20151—
+3K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+3K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem201516—
+3K130716Bioretec Activascrew InterferenceBioretec, Ltd.20130—
+4K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+4K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20212—
+4K182684HammerTechTM Fixation SystemFusion Orthopedics, LLC20180—
+4K171448Hammertoe Correction SystemLife Spine, Inc.20170—
+4K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+4K151270CrossTIE Intraosseous Fixation SystemCrossroads Extremity Systems, LLC201515—
+5K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20241—
+5K181872MIS Bunion SystemCrossroads Extremity Systems, LLC201914—
+6K253423ToeJack MIS Bunion SystemNvision Biomedical Technologies, Inc.20250—
+6K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.20250—
+6K240173Treace Medical Systems (TMC) Plating SystemTreace Medical Concepts, Inc.202441
+6K221181Treace Medical Concepts (TMC) Plating SystemTreace Medical Concepts, Inc.20237—
+6K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K190658MIS Bunion Plating SystemCrossroads Extremity Systems, LLC20192—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+8K243658TMC Compression Implant SystemTreace Medical Concepts20242—