510(k) Report

Devices descending from K063460

21 later devices reach Acumed Congruent Bone Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181843MLP Special Locking Bone Plate SystemMaxxion Medical, LLC / Baumer SA20190—
+1K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+1K103513Lateral Superior Clavicle Plate, Left and Right; Midshaft Superior Clavicle Plate, Left…Advanced Orthopaedic Solutions, Inc.20111—
+1K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions20110—
+1K080184Distal Humeral Plates with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH2008151
+2K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH20260—
+2K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+2K132945CFN-Cannulated Femur Nail, CTN-Cannulated Tibia Nail, CHN-Cannulated Humeral NailI.T.S. GmbH201410—
+2K122623Short Lateral Superior Clavicle Plate, Left and Right Model 3017-000 (Left) and 3018-000…Advanced Orthopaedic Solutions, Inc.20120—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K170972Apex Tibial Nailing SystemOrthoxel20171—
+3K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+3K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+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—
+4K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+5K243890Arthrex Intramedullary NailsArthrex, Inc.20250—
+5K202935Syntec Femoral Nail Extended SystemSyntec Scientific Corporation20200—
+5K191617Syntec Tibial Nail SystemSyntec Scientific Corporation20190—