510(k) Report

Devices descending from K033669

690 later devices reach Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+3K130340Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd.20137—
+3K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+3K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+3K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+3K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH201262
+3K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+3K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+3K112798Locking Compression Plate SystemShanghai Microport Orthopedics Co., Ltd.20120—
+3K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+3K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+3K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+3K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+3K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+3K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+3K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+3K112085Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC20114—
+3K112509Trimed Clavicle Fixation SystemTriMed, Inc.20111—
+3K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+3K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+3K091156Trimed Sterile ProductTriMed, Inc.20090—
+3K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+4K262649Alians ForearmNewclip Technics20260—
+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—
+4K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+4K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+4K261038Xpert PFPNewclip Technics20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K253906Xpert HandNewclip Technics20260—
+4K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+4K253291Excelsior SystemBlue Ocean Global20260—
+4K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+4K253202Hoffmann LRF SystemStryker GmbH20250—
+4K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+4K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+4K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+4K242988Genostis Osteosynthesis SystemGenostis AF20250—
+4K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+4K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+4K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+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—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+4K241539Activmotion SNewclip Technics20240—
+4K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+4K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+4K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+4K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+4K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+4K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+4K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+4K230805TriMed Clavicle Fixation SystemTriMed, Inc.20230—
+4K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+4K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+4K231333STRETTO™ Cable SystemGlobus Medical, Inc.20230—
+4K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+4K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+4K230527WishBone Medical Plate and Screw SystemWishbone Medical, Inc.20230—
+4K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+4K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+4K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+4K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+4K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+4K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+4K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+4K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+4K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+4K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+4K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+4K213591ANTHEM® Fracture SystemGlobus Medical, Inc.20225—
+4K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+4K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+4K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—
+4K212552Correx SoftwareVilex, LLC20210—
+4K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.20210—
+4K203817Tyber Medical Anatomical Plating SystemTyber Medical, LLC202110—
+4K211435PAO Cortical ScrewMedacta International S.A.20210—
+4K203408Summit Patella Plating SystemEndeavor Orthopaedics, LLC20210—
+4K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.20211—
+4K211051DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes20211—
+4K211261Axis Charcot Fixation SystemExtremity Medical, LLC20210—
+4K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC20212—
+4K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211—
+4K210408DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20211—
+4K210060CoLink Mfx Implant SystemIn2bones USA, LLC20211—
+4K201728Versalock Periprosthetic Femur Plates System-GMReisGM Dos Reis Industria e Comercio Ltda.20210—
+4K210268LTJ Screws and WasherAzurmeds, Inc.20210—
+4K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc.20200—
+4K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc.20201—