510(k) Report

Devices descending from K041533

108 later devices reach Synthes (Usa) [Synthes} Peri-Prosthetic Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+1K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+1K1103544.5MM VA-LCP Curved Condylar Plate SystemSynthes USA2011622
+2K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+2K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH20221—
+2K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20212—
+2K162124Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…DePuy Synthes20176—
+2K153379AxSOS 3TiStryker GmbH201625—
+2K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+2K141825IDEAL Locking Plate SystemJiangsu Ideal Medical Science & Technology Co., LT20150—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A20148—
+2K140119Emerge Medical Periarticular and Locking Large Fragment SystemEmerge Medical20141—
+2K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+2K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+3K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+3K253906Xpert HandNewclip Technics20260—
+3K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.20250—
+3K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+3K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+3K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+3K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+3K233912ARIX Cannulated Screw SystemJeil Medical Corporation20240—
+3K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.202402
+3K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+3K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+3K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.20231—
+3K221150Advanced Bone PlateDouble Medical Technology, Inc.20231—
+3K200575Truemed Hand, Foot and Ankle Plates SystemTruemed Group, LLC20210—
+3K200062Foot and Ankle SystemLeith Medical, LLC20210—
+3K200043Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws…Field Orthopaedics Pty, Ltd.20201—
+3K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+3K190391TDM Plate and Screw SystemsTdm Co., Ltd.20191—
+3K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes20190—
+3K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20182—
+3K171320ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS…Meril Healthcare Pvt., Ltd.20182—
+3K172350AxSOS 3 TiStryker GmbH201717—
+3K171293G3™ Active Plate® Miniature SystemGenesis Fracture Care, Inc.20170—
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH201724—
+3K143385Acumed Ankle Plating SystemAcumed, LLC201523—
+3K143061Activ Ankle Locking Plating SystemNewclip Technics20158—
+3K141347Emerge Medical IM Nail SystemEmerge Medical20140—
+3K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG20260—
+4K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH20261—
+4K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH20252—
+4K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc.20251—
+4K243999TriMed Ankle Fixation SystemTriMed, Inc.20252—
+4K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+4K241128TDM Plate and Screw SystemTdm Co., Ltd.20240—
+4K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.20240—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating SystemStryker GmbH20238—
+4K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.20230—
+4K221395Footmotion Plating SystemNewclip Technics20220—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K213214Xpert WristNewclip Technics20210—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K200701Skeletal Dynamics Midshaft Humerus Plating SystemSkeletal Dynamics, Inc.20200—
+4K181091AxSOS 3 TiStryker GmbH201811—
+4K173641Activ AnkleNewclip Technics20183—
+4K170843Alians Fragment SpecificNewclip Technics20171—
+4K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+4K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+4K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC201515—
+5K261511Xpert AnkleNewclip Technics20260—
+5K261191Alians Elbow SNewclip Technics20260—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc.20260—
+5K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K242436Proximal Humerus Fixation SystemSkeletal Dynamics, Inc.20240—
+5K233423Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag SystemTyber Medical, LLC20232—
+5K233017TM Plating SystemTyber Medical, LLC20231—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K212378Arsenal Ankle Plating SystemTrilliant Surgical20220—
+5K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+5K191009Arsenal Plating SystemTrilliant Surgical20192—
+5K181113CoLink™ Afx Plating SystemIn2bones USA, LLC201814—
+5K171372Alians Elbow Locking Plating SystemNewclip Technics20180—
+6K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…TriMed, Inc.20260—
+6K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+6K260810Anteralign LS coverplateTyber Medical, LLC20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+6K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC20251—
+6K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC20242—
+6K213069CoLink NeoFuse Plating SystemIn2bones USA, LLC20211—
+6K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+6K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+6K201149CoLink Plating SystemIn2bones USA, LLC20200—
+6K200762CoLink Cfx Plating SystemIn2bones USA, LLC20201—