510(k) Report

Devices descending from K000684

965 later devices reach Small Fragment Dynamic Compression Locking (DCL) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+4K232115TDM Large Bone Plate and Screw SystemTdm Co., Ltd.20240—
+4K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+4K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+4K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO, Ltd.20242—
+4K231860TDM Screw SystemTdm Co., Ltd.20240—
+4K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+4K231887ARIX Ankle Distal Tibia SystemJeil Medical Corporation20231—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K230591TriLEAP Plating SystemCrossroads Extremity Systems20231—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLC20231—
+4K230257Arthrex Intramedullary NailsArthrex, Inc.20231—
+4K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.20230—
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K230527WishBone Medical Plate and Screw SystemWishbone Medical, Inc.20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+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—
+4K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+4K221342REDEMPTION Beaming SystemVilex, LLC20220—
+4K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH202231
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery, Inc.20220—
+4K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+4K212990Acumed Ankle Syndesmosis Repair SystemAcumed, LLC20220—
+4K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+4K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc.20213—
+4K212640Stratum® Ankle Fusion Plating SystemNextremity Solutions, Inc.20210—
+4K202326BESPA Charcot SystemBespa Global, LLC20210—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K210953SMART Taylor Spatial FrameSmith & Nephew, Inc.20212—
+4K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot…Integra LifeSciences Corporation20210—
+4K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+4K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.20210—
+4K203294Arthrex Pilon Fusion SystemArthrex, Inc.20212—
+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—
+4K201132Arthrex Compression ScrewsArthrex, Inc.202011—
+4K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+4K200538Skeletal Dynamics Forearm Plating SystemSkeletal Dynamics, Inc.20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K193029Conquest FNSmith & Nephew, Inc.202010—
+4K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc.201921
+4K190921Arthrex Low Profile ScrewsArthrex, Inc.20190—
+4K190953Arthrex Minimally Invasive Ankle Fusion PlateArthrex, Inc.20191—
+4K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+4K191009Arsenal Plating SystemTrilliant Surgical20192—
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+4K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+4K181296Syntec Femoral Nail SystemSyntec Scientific Corporation20192—
+4K190586Monster® Screw SystemParagon 28, Inc.201921—
+4K190430OsteoCentric Bone Plate and Screw SystemOsteocentric Trauma20192—
+4K182991EPIC Extremity Fusion Plate SystemEpic Extremity, LLC20190—
+4K182361Arthrex Compression FT ScrewsArthrex, Inc.20184—
+4K182810Distal Radius Plating SystemMiami Device Solutions, LLC20180—
+4K182154Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC20181—
+4K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.20183—
+4K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+4K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+4K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+4K172785Conquest FNSmith & Nephew20178—
+4K172350AxSOS 3 TiStryker GmbH201717—
+4K173135VariAx 2 SystemStryker GmbH201713—
+4K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K163293Colink™ Plating SystemIn2bones USA, LLC2017212
+4K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+4K163650ORTHOLOC® 3Di Ankle Fusion Plating System Line ExtensionWrightmedicaltechnologyinc201712—
+4K170310Alians Clavicle rangeNewclip Technics20170—
+4K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+4K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.20170—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+4K161861APTUS® Coronoid 2.0Medartis AG20170—
+4K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+4K161904GEO Bone Screw SystemGramercy Extremity Orthopeidics, LLC20174—
+4K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+4K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+4K162635Distal Radius Plating SystemMiami Device Solutions, LLC20162—
+4K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K161041OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20160—
+4K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+4K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+4K152686Conquest FNSmith & Nephew201612—
+4K152841Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical ScrewsZimmer, Inc.20150—