510(k) Report

Devices descending from K011978

701 later devices reach Synthes LCP Proximal Tibia Plate through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+4K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+4K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+4K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+4K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+4K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+4K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+4K140565Variax 2 Compression Plating SystemStryker Trauma AG20143—
+4K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+4K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+4K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+4K140376Variax 2 SystemStryker Trauma AG201423—
+4K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+4K133102Flower Ankle Plating SetFlower Orthopedics Corporation20130—
+4K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+4K132502Variax 2 SystemStryker Trauma AG201321—
+4K132642Locking Plate SystemBeijing Libeier Bio-Engineering Institute Co., Ltd.20130—
+4K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+4K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+4K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC20130—
+4K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+4K130774Universal Distal Radius SystemNewclip Technics20135—
+4K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+4K130340Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd.20137—
+4K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+4K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+4K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+4K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH201262
+4K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+4K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+4K112798Locking Compression Plate SystemShanghai Microport Orthopedics Co., Ltd.20120—
+4K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+4K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+4K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+4K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+4K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+4K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+4K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+4K112085Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC20114—
+4K112509Trimed Clavicle Fixation SystemTriMed, Inc.20111—
+4K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+4K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+4K091156Trimed Sterile ProductTriMed, Inc.20090—
+4K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+5K262649Alians ForearmNewclip Technics20260—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K261038Xpert PFPNewclip Technics20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+5K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+5K253291Excelsior SystemBlue Ocean Global20260—
+5K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+5K253202Hoffmann LRF SystemStryker GmbH20250—
+5K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+5K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC20250—
+5K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+5K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+5K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+5K242988Genostis Osteosynthesis SystemGenostis AF20250—
+5K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+5K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+5K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+5K250055BPS - Bone Fragment Fixation Plates, Screws and WashersOrthonovis, Inc.20251—
+5K241599Signature Osteosynthesis Plate SystemSignature Orthopaedic Pty, Ltd.20250—
+5K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+5K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+5K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+5K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—
+5K233873XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited20240—
+5K233919VariAx 2 Distal Radius SystemStryker GmbH20242—
+5K231684Quick - Radius Disposable SetGM Dos Reis Industria e Comercio Ltda.20240—
+5K232652Anatomical Plating System (various)Tyber Medical, LLC2023320
+5K232693Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20231—
+5K231649Intraosseous Fusion Device SystemAuxano Medical, LLC20230—
+5K230805TriMed Clavicle Fixation SystemTriMed, Inc.20230—
+5K231262Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System…Stryker GmbH20234—
+5K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH20231—
+5K231461Smart Correction System (HA Half Pins)Wishbone Medical, Inc.20231—
+5K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies20230—
+5K230527WishBone Medical Plate and Screw SystemWishbone Medical, Inc.20230—
+5K222465Tyber Medical Anatomical Plating SystemTyber Medical, LLC20239—
+5K223786Orthex External Fixation SystemOrthoPediatrics Corp.20232—
+5K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical Devices20230—
+5K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and…Avanti Orthopaedics, Inc.20221—
+5K213014Varixis Elbow SystemAuxein Medical Private Limited20220—
+5K221360Medline UNITE® Medial Malleolus Peg Plate SystemMedline Industries, LP20220—
+5K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.20221—
+5K221792Acute QC Strut and ComponentsSmith & Nephew, Inc.20220—
+5K221366Smart Correction System Rings and Compatible HA-Coated Half PinsWishbone Medical, Inc.20221—
+5K213698CoLink PCR Plating SystemIn2bones USA, LLC20220—
+5K212348ALPHALOK™ Plating SystemVilex, LLC20223—
+5K203773BRM TOOL ScrewsBrm Extremities Srl20221—
+5K212487CoLink Vallux Plating SystemIn2bones USA, LLC20214—
+5K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20217—