510(k) Report

Devices descending from K001941

800 later devices reach Synthes Modular Foot System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+4K191972ARIX Wrist SystemJeil Medical Corporation20190—
+4K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+4K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K182785LOQTEQ VA Foot Plates 2.5Aap Implantate AG20190—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K182307Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail SystemParagon 28, Inc.20198—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+4K181067AlignX Ankle Fusion SystemExtremity Medical, LLC20184—
+4K180808Omni Foot Plating SystemExtremity Medical, LLC20183—
+4K173746Activmotion RangeNewclip Technics20181—
+4K173293EVOS Small Fragment Upper Extremity PlatesSmith & Nephew, Inc.201812—
+4K170972Apex Tibial Nailing SystemOrthoxel20171—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K162874Cannulated Screws NeoorthoNeoortho Produtos Ortopedicos S/A20170—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K170457EVOS Small Fragment Lower Extremity PlatesSmith & Nephew, Inc.2017131
+4K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+4K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+4K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+4K163440Stealth Staple SystemFirst Ray, LLC20173—
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K162179osteo-WEDGE II ® Open Wedge Bone Locking Plate SystemGraham Medical Technologies, LLC Dba Gramedica20170—
+4K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+4K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+4K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+4K153065The Hammertoe Correction SystemLife Spine, Inc.20162—
+4K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+4K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+4K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+4K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K143721PRCT2Fx Solutions20150—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+4K150626Rush Medullary PinsZimmer, Inc.20150—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K150309Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20150—
+4K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K141241Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC20145—
+4K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+4K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+4K141228Aos 6.5MM Captured, Fully Threaded Cancellous ScrewAdvanced Orthopaedic Solutions, Inc.20142—
+4K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+4K140792Salvation 3DI Plating SystemWrightmedicaltechnologyinc201421
+4K140408Salvation Osteopenic ScrewWrightmedicaltechnologyinc20141—
+4K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+4K140216Orthopedic Fixation SystemsImpact Medical, LLC20140—
+4K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+4K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+4K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc.2014462
+4K130614Bone Fragment and Fixation Plates, Screws and WashersLaura Cattabriga20142—
+4K132502Variax 2 SystemStryker Trauma AG201321—
+4K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+4K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+4K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+4K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+4K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+4K120689Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC201228—
+4K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+4K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+4K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+4K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+4K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+4K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+4K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+4K091156Trimed Sterile ProductTriMed, Inc.20090—
+4K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009487—
+5K262649Alians ForearmNewclip Technics20260—
+5K254280F.A.S.T ScrewSteps Ortho20260—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+5K252246Leforte MMF SystemJeil Medical Corporation20260—
+5K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+5K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+5K251135Treace Medical Concepts (TMC) Implant Fixation SystemTreace Medical Concepts20251—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K250155Xpert KneeNewclip Technics20250—
+5K243610APTUS Hand System; APTUS Elbow Dorsal OlecranonMedartis AG20252—
+5K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc.20250—
+5K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.20250—