510(k) Report

Devices descending from K091144

21 later devices reach Synthes Matrixmandible Preformed Reconstruction Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192655Depuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+1K122647Synthes Patient Specific PlateSynthes, Inc.20135—
+1K113251Synthes Matrixmandible Performed Reconstruction PlatesSynthes, Inc.20110—
+1K102641Mini and Micro Fragments Reconstruction System-NeofaceNeoortho Produtos Ortopedicos S/A201012—
+2K193280MedCAD® AccuPlate® Patient-Specific PlateMedcad20210—
+2K180204CranioMaxillofacial Fixation (CMF) System - CMF VisionareVisionare, LLC20182—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+2K132519Stryker Customized Mandible Recon Plate KitStryker20133—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K193136Stryker Customized Mandible Recon Plate KitStryker20201—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K182758MCI - CMF SystemMci Medical Concept Innovation, Inc.20190—
+3K190696Stryker Surgeon iD Mandible Recon PlateStryker20190—
+3K182609Delphos Implants Rigid Fixation SystemDelphos Implants - Ind.Com. Importacao E Exportacao DE20190—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf)20220—