510(k) Report

Devices descending from K000558

27 later devices reach Synthes (Usa) Wrist Fusion Plates (WFP) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+1K151178VariAx 2 Wrist Fusion SystemStryker Trauma AG20150—
+1K131380Acumed Totalw Rist Fusion Plating SystemAcumed, LLC20130—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+1K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128—
+1K100123Acumed Wrist Arthrodesis Plate SystemAcumed, LLC20101—
+1K093163Integra Total Wrist Fusion SystemIntegra LifeSciences Corporation20090—
+1K052754Wrist Fusion PlateDvo Extremity Solutions, LLC20052—
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K192297APTUS Wrist Arthrodesis PlatesMedartis AG20197—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K232144Sterile Products of the APTUS SystemMedartis AG20233—
+3K223853Medartis APTUS® Ulna PlatesMedartis AG20235—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+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—
+4K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+4K232105APTUS Foot System 2.8-3.5Medartis AG20240—
+4K234062APTUS Hand Scaphoid PlatesMedartis AG20243—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+5K260761APTUS Clavicle System 2.8Medartis AG20260—
+5K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5Medartis AG20260—