510(k) Report

Devices descending from K060736

531 later devices reach Smith & Nephew 6.5MM and 8.0MM Cannulated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+3K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+3K190166TriMed Nitinol Staple SystemTriMed, Inc.20190—
+3K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.20191—
+3K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+3K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+3K182154Depuy Synthes Femoral Neck SystemSynthes (USA) Products, LLC20181—
+3K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+3K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+3K173121Ankle Fusion Plating SystemIn2bones Sas20172—
+3K172213MECRON Cannulated Screw SystemMerete GmbH20170—
+3K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw SystemExtremity Medical, LLC201724—
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+3K170887EVOS Small Fragment Plating SystemSmith & Nephew, Inc.201713—
+3K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+3K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+3K161894SurgTech Trauma SystemSurgtech, Inc.20173—
+3K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+3K161665VLP Wrist Fracture SystemSmith & Nephew, Inc.201610—
+3K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+3K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+3K160633G3(TM) Active Plate (R) Small Fragment SystemGenesis Fracture Care, Inc.20160—
+3K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K153395OS2-C Compression StapleIn2bones Sas20167—
+3K153378Monster BITE Screw SystemParagon 28201522—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K142581APTUS Foot SystemMedartis AG201522—
+3K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+3K143365Eminent Foot Plate SystemEminent Spine20151—
+3K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+3K142938G3 Active Plate Large Fragment SystemGenesis Fracture Care, Inc.20143—
+3K142520Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc.201431
+3K142442Magna-FX and Mini Magna-FX Cannulated Screw Fixation SystemZimmer, Inc.2014153
+3K142418I.T.S. Hand Locking Plates System - HLSI.T.S. GmbH201411
+3K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+3K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+3K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+3K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG201426—
+3K140357Oic Variable Angle Small Fragment Locking Plate SystemOrthopaedic Implant Company20142—
+3K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+3K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+3K140376Variax 2 SystemStryker Trauma AG201423—
+3K132296D-Rad Smart PackSmith & Nephew, Inc.2014114
+3K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+3K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+3K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+3K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+3K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+3K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+3K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+3K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+3K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+3K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+3K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+3K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+3K090656Intertan CHS Limited Collapse Set ScrewSmith & Nephew, Inc.200934—
+4K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+4K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+4K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+4K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+4K253906Xpert HandNewclip Technics20260—
+4K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+4K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—
+4K253764ENOS Software Guided External Fixation SystemDisior, Ltd.20260—
+4K253291Excelsior SystemBlue Ocean Global20260—
+4K253178TRILEAP Plating SystemCrossroads Extremity Systems20260—
+4K253202Hoffmann LRF SystemStryker GmbH20250—
+4K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemBonebridge AG20250—
+4K252625The Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC20250—
+4K251555Ultra™ Compression Screw SystemPace Surgical20251—
+4K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250—
+4K250620KLS Martin Ixos SystemKLS Martin L.P.20250—
+4K250472SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Amdt Holdings, Inc.20250—
+4K251361Tyber Medical Distal Radius Plating SystemTyber Medical, LLC20250—
+4K242988Genostis Osteosynthesis SystemGenostis AF20250—
+4K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG20251—
+4K243469SignexOsteonic Co., Ltd.20250—
+4K251128Extremity Medical External Fixation SystemExtremity Medical, LLC20250—
+4K250494The OsteoCentric Bone Plate and Screw SystemOsteoCentric Technologies20251—
+4K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+4K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical20242—
+4K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+4K242596Versalock Mini and Micro Plating SystemGM Dos Reis Industria e Comercio Ltda.20242—
+4K242814Tandry Q-Locking Plate SystemMicroware Precision Co., Ltd.20240—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…Stryker GmbH20240—
+4K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.20241—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—