510(k) Report

Devices descending from K011978

701 later devices reach Synthes LCP Proximal Tibia Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K241539Activmotion SNewclip Technics20240—
+4K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+4K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AG20231—
+4K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+4K230141LOQTEQ® VA Elbow Plates 2.7/3.5 SystemAap Implantate AG20230—
+4K221621Pro-X1™ Trochanteric Nailing SystemX-Bolt Orthopedics20230—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc.20230—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K213572JuniOrtho Plating System™Orthofix Srl20220—
+4K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+4K213214Xpert WristNewclip Technics20210—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K202326BESPA Charcot SystemBespa Global, LLC20210—
+4K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+4K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+4K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+4K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+4K203479ExtremiLOCK Lateral Ankle Fusion PlatesOsteomed20210—
+4K200062Foot and Ankle SystemLeith Medical, LLC20210—
+4K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV…Smith & Nephew20205—
+4K202307Activ FuseNewclip Technics20200—
+4K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+4K193368Smart Correction SystemWishbone Medical, Inc.202031
+4K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+4K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+4K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+4K193029Conquest FNSmith & Nephew, Inc.202010—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+4K191848APTUS Wrist Spanning Plates 2.5Medartis AG20192—
+4K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+4K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+4K182650Arzzt Distal Radius and Ulna SystemTruemed Group, LLC20191—
+4K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+4K190586Monster® Screw SystemParagon 28, Inc.201921—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K182154Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC20181—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+4K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+4K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+4K173826THP Hip Fracture Plating SystemBiomet, Inc.20180—
+4K172189Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt &…Truemed Group, LLC20180—
+4K172785Conquest FNSmith & Nephew20178—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K162380Locking Plate SystemBeijing Keyi Medical Device Technology Co., Ltd.20170—
+4K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+4K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+4K170310Alians Clavicle rangeNewclip Technics20170—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+4K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+4K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+4K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+4K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+4K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+4K161058Cannulated ScrewMiami Device Solutions, LLC20161—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K160995NEOVIEW Plating SystemIn2bones Sas201624
+4K153379AxSOS 3TiStryker GmbH201625—
+4K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+4K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+4K152686Conquest FNSmith & Nephew201612—
+4K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K151508IRENE Locking Compression Plate SystemTianjin Zhengtian Medical Instrument Co., Ltd.20160—
+4K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+4K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+4K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+4K152000SMV Scientific Bone Plate and Screw SystemSmv Scientific20153—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+4K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+4K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+4K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+4K151418Monster Screw SystemParagon 28201527—
+4K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+4K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+4K142581APTUS Foot SystemMedartis AG201522—
+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—
+4K142502Alians Ulna Locking Plating SystemNewclip Technics20142—