510(k) Report

Devices descending from K000682

340 later devices reach Synthes Large Fragment Dynamic Compression Locking (DCL) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.2014322
+3K133930Flower Rear Foot Plating Set, Flower Calcaneus Planting Set, Flower Rearfoot Plating SetFlower Orthopedics Corporation201406
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+3K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+3K132502Variax 2 SystemStryker Trauma AG201321—
+3K130810Zimmer Motionloc Screw for Periarticular Locking Plate SystemZimmer, Inc.20131—
+3K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC20130—
+3K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+3K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH201262
+3K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+3K112085Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC20114—
+4K262344Large Compression ScrewsTriMed, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K261038Xpert PFPNewclip Technics20260—
+4K261241TriMed Compression ScrewsTriMed, Inc.20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K253300Fine Osteotomy™Bodycad Laboratories, Inc.20250—
+4K252600Pediatric Plating Platform I Small-MiniOrthoPediatrics Corp.20250—
+4K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC20250—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K241666EVOS Pelvic and Acetabular SystemSmith & Nephew20250—
+4K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K242995OIC Small / Mini Fragment Plate SystemThe Orthopaedic Implant Company20240—
+4K240487EVOS Patella PlatesSmith & Nephew20240—
+4K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO, Ltd.20241—
+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
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K230204ALPHALOK Plating SystemVilex, LLC20230—
+4K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+4K230527WishBone Medical Plate and Screw SystemWishbone Medical, Inc.20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO, Ltd.20224—
+4K221558ALPHALOK Plating SystemVilex, LLC20222—
+4K213123EVOS Wrist Spanning PlateSmith & Nephew, Inc.20220—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K220937Arthrex Mini Fragment SystemArthrex, Inc.20222—
+4K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH20224—
+4K213572JuniOrtho Plating System™Orthofix Srl20220—
+4K213596OSSIOfiber Compression Screw, 3.5mmOSSIO, Ltd.20214—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K211290Cannulated Fasteners and NutsOsteoCentric Technologies20212—
+4K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+4K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.20210—
+4K200246JPS JuniOrtho Plating SystemOrthofix Srl20201—
+4K193614FINE Osteotomy around the kneeBodycad Laboratories, Inc.20204—
+4K190842Comus Locking Plate systemsJiangsu Trauhui Medical Instrument Co., Ltd.20200—
+4K191118Avanti Distal Radius and Forearm SystemAvanti Orthopaedics, Inc.20191—
+4K190430OsteoCentric Bone Plate and Screw SystemOsteocentric Trauma20192—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+4K173641Activ AnkleNewclip Technics20183—
+4K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+4K172350AxSOS 3 TiStryker GmbH201717—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K170727VariAx 2 Compression Plating SystemStryker GmbH20172—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.20170—
+4K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+4K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+4K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+4K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+4K140769Variax 2 SystemStryker Trauma AG201419—
+5K261511Xpert AnkleNewclip Technics20260—
+5K261191Alians Elbow SNewclip Technics20260—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+5K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+5K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+5K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+5K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+5K233816REDEMPTION Charcot Plating SystemVilex, LLC20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—
+5K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—