510(k) Report

Devices descending from K062352

527 later devices reach FRS Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K172785Conquest FNSmith & Nephew20178—
+3K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+3K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+3K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+3K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+3K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+3K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+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
+3K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+3K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+3K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+3K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+3K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+3K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+3K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+3K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+3K152686Conquest FNSmith & Nephew201612—
+3K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+3K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+3K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+3K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+3K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical20150—
+3K151146N-Force Fixation SystemInnovision, Inc.20151—
+3K151418Monster Screw SystemParagon 28201527—
+3K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+3K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+3K150626Rush Medullary PinsZimmer, Inc.20150—
+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—
+3K142776Flow-ScrewFlow-Fx, LLC20151—
+3K143050VLP Mini-Mod Small Bone Plating System 1.5mm Plates and ScrewsSmith & Nephew, Inc.20148—
+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
+3K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+3K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+3K140376Variax 2 SystemStryker Trauma AG201423—
+3K132244N-Force Fixation SystemInnovision, Inc.20143—
+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—
+3K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+3K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+3K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+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—
+4K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+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—
+4K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+4K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+4K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+4K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+4K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+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—
+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—
+4K243798Orthex External Fixation SystemOrthoPediatrics Corp.20251—
+4K241563Extremity Medical External Fixation SystemExtremity Medical, LLC20251—
+4K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA…Bonebridge AG20241—
+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—
+4K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG20241—
+4K242554Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20241—
+4K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric Technologies20240—
+4K241815Protean Fragment Plating SystemSkeletal Dynamics, Inc.20240—
+4K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC20240—
+4K240613APTUS Elbow Dorsal Olecranon PlatesMedartis AG20244—