510(k) Report

Devices descending from K982222

716 later devices reach Synthes (Usa) Distal Femur Plate (DFP) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+5K162307OrthoPediatrics Locking Proximal Femur System Cortical ScrewsOrthoPediatrics Corp.20161—
+5K152289Alians Elbow Locking Plating SystemNewclip Technics20166—
+5K161292Distal Radius Plating SystemMiami Device Solutions, LLC20164—
+5K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+5K160995NEOVIEW Plating SystemIn2bones Sas201624
+5K153379AxSOS 3TiStryker GmbH201625—
+5K160177Gridlock Ankle Plating SystemTrilliant Surgical, Ltd.201631
+5K160191Align Anterior Ankle Fusion PlateExtremity Medical, LLC20165—
+5K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+5K152686Conquest FNSmith & Nephew201612—
+5K160002Piccolo Composite (R) Distal Volar Radius Plate SystemCarboFix Orthopedics, Ltd.20164—
+5K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+5K151508IRENE Locking Compression Plate SystemTianjin Zhengtian Medical Instrument Co., Ltd.20160—
+5K151735TriMed Humeral Supracondylar Fixation SystemTriMed, Inc.20160—
+5K152145OsteoMed ExtremiLOCK Wrist Plating SystemOsteomed20151—
+5K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC20157—
+5K152000SMV Scientific Bone Plate and Screw SystemSmv Scientific20153—
+5K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+5K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC20159—
+5K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+5K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+5K142943Metallic Locking Bone Plate and ScrewCanwell Medical Co., Ltd.20150—
+5K151418Monster Screw SystemParagon 28201527—
+5K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd.20151—
+5K143496Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.20154—
+5K142581APTUS Foot SystemMedartis AG201522—
+5K143365Eminent Foot Plate SystemEminent Spine20151—
+5K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+5K142502Alians Ulna Locking Plating SystemNewclip Technics20142—
+5K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+5K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+5K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+5K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+5K142306Flower Upper Extremity Plating SetFlower Orthopedics Corporation20140—
+5K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+5K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+5K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+5K141430Variax Distal Radius Plating SystemStryker Leibinger GmbH & Co KG201412—
+5K140565Variax 2 Compression Plating SystemStryker Trauma AG20143—
+5K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+5K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+5K140397Paralock Plating System / Tuffnek ScrewParagon 28201431—
+5K140376Variax 2 SystemStryker Trauma AG201423—
+5K133691Extrimilock Ankle Plating SystemOsteomed LP201410—
+5K132248Flower Bone Screw SetFlower Orthopedics Corporation20131—
+5K132502Variax 2 SystemStryker Trauma AG201321—
+5K132642Locking Plate SystemBeijing Libeier Bio-Engineering Institute Co., Ltd.20130—
+5K132774Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd.20133—
+5K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd.20131—
+5K130731Stabiliz Fixation System - SPL Locking ScrewStabiliz Orthopaedics, LLC20130—
+5K130008Distal Ulna Locking Plate (Dul), Ulna Osteotomy Locking Plate (Uol), 3.0 Cancellous…I.T.S. GmbH201311
+5K130774Universal Distal Radius SystemNewclip Technics20135—
+5K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+5K130340Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd.20137—
+5K120409Piccolo Composite Plate SystemCarboFix Orthopedics, Ltd.201211—
+5K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH201262
+5K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+5K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+5K112798Locking Compression Plate SystemShanghai Microport Orthopedics Co., Ltd.20120—
+5K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211—
+5K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+5K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+5K113405Suspension Clavicle Fracture Repair SystemSuspension Orthopaedic Solutions, LLC20120—
+5K112923Suspension Clavicle Fracture Fixation SystemSuspension Orthopaedic Solutions, LLC20110—
+5K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited20118—
+5K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+5K112085Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC20114—
+5K112509Trimed Clavicle Fixation SystemTriMed, Inc.20111—
+5K101930Memometal Navis Bone Plating SystemMemometal Technologies20110—
+5K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+5K091156Trimed Sterile ProductTriMed, Inc.20090—
+5K082078Zimmer Periarticular Locking Plate System: Distal Humeral and Proximal Ulna PlatesZimmer, Inc.200847
+5K063166I.T.S. Pelvic Reconstruction SystemI.T.S. Implantat-Technologie-Systeme GmbH200692
+6K262649Alians ForearmNewclip Technics20260—
+6K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+6K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+6K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+6K261511Xpert AnkleNewclip Technics20260—
+6K261191Alians Elbow SNewclip Technics20260—
+6K261481Pangea Femur Reconstruction SystemStryker GmbH20260—
+6K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+6K261038Xpert PFPNewclip Technics20260—
+6K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+6K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+6K260934TITAN Nail; APTUS K-Wire SystemMedartis AG20260—
+6K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+6K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+6K253291Excelsior SystemBlue Ocean Global20260—
+6K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+6K253202Hoffmann LRF SystemStryker GmbH20250—
+6K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+6K252356The Acumed Wrist Fixation System - 2.4mm ScrewsAcumed, LLC20250—
+6K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+6K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+6K251945TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)TriMed, Inc.20251—
+6K242988Genostis Osteosynthesis SystemGenostis AF20250—
+6K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+6K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+6K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—