510(k) Report

Devices descending from K925098

11 later devices reach Biofix Absorbable Self-Reinforced Poly-L-Lactide through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…Xtremi-T, LLC20051—
+1K040500Arthrotek LactonailArthrotek, Inc.20042—
+1K993074Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd.19997—
+2K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150—
+2K070178Aesculap Resorbable Pin, Model FR735Aesculap Implant System, Inc.20070—
+2K041288Modification to SmartpinLinvatec Biomaterials, Inc.20042—
+2K0319812.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd.20033—
+2K013546Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc.20014—
+2K0120001.5MM Bone Fixation KitBionx Implants, Ltd.20015—
+3K073311Osteotrans-OT PinTakiron Co., Ltd.20080—
+3K071616Arc Surgical Biotrak Pin SystemArc Surgical, LLC20070—