510(k) Report

Devices descending from K041786

13 later devices reach Calcamea Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090582Calcaneal Fracture Plate SystemTornier, Inc.200912—
+2K132898A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp201311—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K221346Stryker VariAx 2 MIS CalcaneusStryker GmbH20220—
+3K221395Footmotion Plating SystemNewclip Technics20220—
+3K171808TDM Plate and Screw SystemTdm Co., Ltd.20186—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—