510(k) Report

Devices descending from K081353

35 later devices reach Synthes (Usa) Tomofix Medial Distal Femur Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212545FlexitSystem Knee osteotomy systemNeosteo20220—
+1K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+1K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+1K141796Depuy Synthes Tomofix Osteotomy SystemSynthes (USA) Products, LLC201414—
+1K131782Loqteq High Tibia Osteotomy Plate 4.5Aap Implantate AG20130—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+2K260090SMART Osteotomy SystemActis Medical Pty., Ltd.20260—
+2K243469SignexOsteonic Co., Ltd.20250—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K241356Fine Osteotomy™Bodycad Laboratories, Inc.20243—
+2K241539Activmotion SNewclip Technics20240—
+2K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+2K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+2K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20184—
+2K173746Activmotion RangeNewclip Technics20181—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+3K250394Fine TTO™Bodycad Laboratories, Inc.20250—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K250923Fine Osteotomy™Bodycad Laboratories, Inc.20251—
+3K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+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—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K253300Fine Osteotomy™Bodycad Laboratories, Inc.20250—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+5K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—