510(k) Report

Devices descending from K011335

840 later devices reach Synths One-Third Tubular DCL Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161327Syntec Humeral Nail SystemSyntec Scientific Corporation20173—
+4K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+4K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+4K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+4K170214Additive Orthopaedics Locking Lattice PlateAdditive Orthopaedics, LLC20178—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K162391AlignMATE™ Lapidus Arthrodesis SystemArthrosurface, Inc.20170—
+4K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+4K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+4K162078EVOS Small Fragment Plating SystemSmith & Nephew, Inc.2016261
+4K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+4K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+4K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+4K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+4K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+4K152686Conquest FNSmith & Nephew201612—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K153395OS2-C Compression StapleIn2bones Sas20167—
+4K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+4K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+4K152974ORTHOLOC® 3Di Foot Plating Reconstruction SystemWrightmedicaltechnologyinc201522—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K151456Small Bone Nail ImplantVilex IN Tennessee, Inc.20150—
+4K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K151418Monster Screw SystemParagon 28201527—
+4K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+4K150626Rush Medullary PinsZimmer, Inc.20150—
+4K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156—
+4K142581APTUS Foot SystemMedartis AG201522—
+4K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+4K143402Extremity Medical Calcaneal Osteotomy DeviceExtremity Medical, LLC20151—
+4K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+4K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+4K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+4K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+4K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+4K141241Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC20145—
+4K140431Pediloc Fragment SystemOrthoPediatrics Corp.20141—
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+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—
+4K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+4K140376Variax 2 SystemStryker Trauma AG201423—
+4K140259Variax Clavicle Hook PlateStryker Trauma AG201413—
+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
+4K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+4K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation2013142
+4K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG201316—
+4K122538Acumed Pelvic Bone Plate SystemAcumed, LLC201241
+4K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+4K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+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—
+4K111678Ortho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited2012581
+4K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+4K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+4K111266Easylock OsteosystemTriMed, Inc.20110—
+4K110086Ifs Profile Plates, Screws, and WashersInternal Fixation Systems, Inc.20115—
+4K110959Orthopediatrics Blade Plate SystemOrthoPediatrics Corp.201123
+4K111326Osteowedge Opening Wedge Bone Locking SystemGraham Medical Technologies, LLC20111—
+4K111086Orthopediatrics Fracture and Osteotomy Bone Plate SystemOrthoPediatrics Corp.201171
+4K103705Low Profile ScrewsArthrex, Inc.2011219—
+4K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+4K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+4K102095Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20102—
+4K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc.201056—
+4K100240Orthopediatrics Pediloc Tibia Plate SystemOrthoPediatrics Corp.201013—
+4K093983Smple Plate and ScrewsBiomet Trauma (Aka Ebi, Lp)20100—
+4K092670Biodrive Micro Screw SystemEbi,Llc D/B/A Biomet Trauma200968—
+4K091156Trimed Sterile ProductTriMed, Inc.20090—
+4K063820Lisfranc PlateNew Deal, S.A.20070—
+4K070241Modification to Lapidus PlateNew Deal, S.A.200701
+5K262975Arthrex Beaming SystemArthrex, Inc.20260—
+5K262618Arthrex Spine Compression FT ScrewArthrex, Inc.20260—
+5K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies20260—
+5K262344Large Compression ScrewsTriMed, Inc.20260—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K261241TriMed Compression ScrewsTriMed, Inc.20260—
+5K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.20260—
+5K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+5K253906Xpert HandNewclip Technics20260—
+5K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.20260—
+5K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+5K253291Excelsior SystemBlue Ocean Global20260—
+5K252807Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PlatesArthrex, Inc.20260—
+5K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—