510(k) Report

Devices descending from K041911

237 later devices reach Synthes (Usa) LCP Curved Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+3K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+3K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+3K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+3K140565Variax 2 Compression Plating SystemStryker Trauma AG20143—
+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—
+3K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+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—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K261038Xpert PFPNewclip Technics20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC20250—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+4K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+4K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+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—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K213572JuniOrtho Plating System™Orthofix Srl20220—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+4K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.20210—
+4K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208—
+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—
+4K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810—
+4K173556Injection ScrewBiedermann Medtech, Inc.20180—
+4K173746Activmotion RangeNewclip Technics20181—
+4K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC201841
+4K173641Activ AnkleNewclip Technics20183—
+4K172786MDS Plating SystemMiami Device Solutions, LLC20170—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711—
+4K170727VariAx 2 Compression Plating SystemStryker GmbH20172—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K163003Y3 Proximal Femoral Plate SystemPega Medical, Inc.20170—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+4K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+4K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC20166—
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+4K151010Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.201521
+4K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+4K140769Variax 2 SystemStryker Trauma AG201419—
+5K261511Xpert AnkleNewclip Technics20260—
+5K261191Alians Elbow SNewclip Technics20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+5K251913OsteoCentric® UnifiMI® TCS Plating SystemOsteoCentric Technologies20250—
+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—
+5K241539Activmotion SNewclip Technics20240—
+5K234059Forma Medical Optimal Plating SystemForma Medical, Inc.20240—
+5K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+5K233089NeoSpan® Compression Implant SystemIn2bones USA, LLC20240—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™…Crossroads Extremity Systems, LLC20232—
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+5K212433Anthem Fracture SystemGlobus Medical, Inc.20217—
+5K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+5K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+5K193452MotoBAND CP Implant SystemCrossroads Extemity Systems, LLC20203—
+5K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+5K191009Arsenal Plating SystemTrilliant Surgical20192—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+5K173652Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20170—
+5K173135VariAx 2 SystemStryker GmbH201713—
+5K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH20174—
+5K153536Piccolo Composite® Nailing SystemCarboFix Orthopedics, Ltd.201611
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—