510(k) Report

Devices descending from K003659

43 later devices reach Plga Pin, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061164ActivapinBioretec, Ltd.200637—
+1K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…Xtremi-T, LLC20051—
+1K041288Modification to SmartpinLinvatec Biomaterials, Inc.20042—
+2K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+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—
+2K073311Osteotrans-OT PinTakiron Co., Ltd.20080—
+2K071616Arc Surgical Biotrak Pin SystemArc Surgical, LLC20070—
+2K071863Activapin, Nexfix RFS Pin, Nexfix Resorbable Fixation System (RFS)Bioretec, Ltd.20070—
+2K062980ActivascrewBioretec, Ltd.20061—
+3K202777VeriFixx™ Small Bone ImplantArmis Biopharma, Inc.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—
+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—
+7K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.20261—
+7K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K233154SkyOPS™ Orthopedic Plate SystemSky Surgical, LLC20231—
+8K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K251732Wrist Fracture SystemMet One Technologies, LLC20260—
+8K243658TMC Compression Implant SystemTreace Medical Concepts20242—