510(k) Report

Devices descending from K090582

12 later devices reach Calcaneal Fracture Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132898A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp201311—
+2K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+2K221346Stryker VariAx 2 MIS CalcaneusStryker GmbH20220—
+2K221395Footmotion Plating SystemNewclip Technics20220—
+2K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+3K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+3K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—