510(k) Report

Devices descending from K080184

15 later devices reach Distal Humeral Plates with Angular Stability through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+1K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+1K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+2K170972Apex Tibial Nailing SystemOrthoxel20171—
+2K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+2K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+3K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+3K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+3K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+3K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+3K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+4K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+4K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+4K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—