510(k) Report

Devices descending from K011262

547 later devices reach Modification to the Bold Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K200987LTJ Screws and WasherAzurmeds, Inc.20201—
+4K193368Smart Correction SystemWishbone Medical, Inc.202031
+4K201578DePuy Synthes Variable Angle Locking Patella Plating SystemSynthes (USA) Products, LLC20203—
+4K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC20201—
+4K201149CoLink Plating SystemIn2bones USA, LLC20200—
+4K201556Intraosseous Fixation SystemExtremity Medical, LLC20200—
+4K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH20209—
+4K193029Conquest FNSmith & Nephew, Inc.202010—
+4K193222Tyber Medical Anatomical Plating SystemTyber Medical, LLC202011—
+4K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…In2bones USA, LLC20200—
+4K182718Mini and Micro Fragments Reconstruction System – GMReisGm Dos Reis Industria E Comerico Ltda.20194—
+4K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20195—
+4K192592Axis Plating SystemExtremity Medical, LLC20190—
+4K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH201910—
+4K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLC20190—
+4K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…In2bones USA, LLC20190—
+4K190992OrthoPediatrics PediFoot Deformity Corrections SystemOrthoPediatrics Corp.20190—
+4K191535CoLink® Mini Plating SystemIn2bones USA, LLC20196—
+4K190069SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)Arrowhead De, LLC20193—
+4K183011Additive Orthopaedics Patient Specific 3D Locking Lattice PlatesAdditive Orthopaedics20195—
+4K182015Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20181—
+4K180539Deformity Analysis and Correction Software (DACS) and InstrumentationArrowhead Medical Device Technologies, LLC20184—
+4K181533EVOS Wrist Fracture Plating SystemSmith & Nephew, Inc.20189—
+4K180377Fracture and Correction SystemIn2bones USA, LLC20187—
+4K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLC20180—
+4K173641Activ AnkleNewclip Technics20183—
+4K172785Conquest FNSmith & Nephew20178—
+4K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC20174—
+4K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.201711—
+4K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170—
+4K170687Flower Bone Screw SetFlower Orthopedics Corporation20170—
+4K170401Piccolo Composite® Plate SystemCarboFix Orthopedics, Ltd.20173—
+4K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc.201774—
+4K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND…Greens Surgicals Pvt., Ltd.20173—
+4K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714—
+4K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited201731
+4K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc.20174—
+4K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc.20160—
+4K1609464.0 and 6.5 Cancellous Bone Screw and WasherSmv Scientific20161—
+4K161778ToeTac™ 10° Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20160—
+4K160791AmorChem Titanium Porous Fixation DeviceAmorchem Holdings, Inc.20160—
+4K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC20168—
+4K161539Arthrosurface Bone ScrewsArthrosurface, Inc.20162—
+4K151881X-Fix Line AdditionsVilex IN Tennessee, Inc.201672
+4K152686Conquest FNSmith & Nephew201612—
+4K151708RECON system - Compression ScrewsNormed Medizin-Technik GmbH20160—
+4K152976VLP Mini-Mod Talus PlatesSmith & Nephew, Inc.20158—
+4K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH201524
+4K152072CrossRoads Screw SystemCrossroads Extremity Systems, LLC20153—
+4K151146N-Force Fixation SystemInnovision, Inc.20151—
+4K151418Monster Screw SystemParagon 28201527—
+4K150889Suture Wires and Wire LoopsZimmer, Inc.20152—
+4K150443ToeTac Hammertoe Fixation SystemRestore Surgical, LLC Dba Instratek20151—
+4K150626Rush Medullary PinsZimmer, Inc.20150—
+4K142581APTUS Foot SystemMedartis AG201522—
+4K141527Depuy Synthes Variable Angle Locking Hand SystemSynthes USA20157—
+4K143365Eminent Foot Plate SystemEminent Spine20151—
+4K150099Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)Synthes (USA) Products, LLC201514—
+4K142776Flow-ScrewFlow-Fx, LLC20151—
+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
+4K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl201432—
+4K140550Orthohub External Fixator SoftwareOrthohub, Inc.20145—
+4K141784Ortho Solutions Ultos Plating SystemOrtho Solutions Limited2014282
+4K140741Salvation Beams and Bolts SystemWrightmedicaltechnologyinc201434—
+4K140617Pinit Small Bone Fusion SystemArthrosurface, Inc.20144—
+4K140376Variax 2 SystemStryker Trauma AG201423—
+4K132244N-Force Fixation SystemInnovision, Inc.20143—
+4K123347Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0Normed Medizin-Technik GmbH201322
+4K131324Maxtorque Screw SystemOrthohelix Surgical Designs, Inc.20132—
+4K121425Ortholoc 3DI Ankle Fusion Plating SystemWrightmedicaltechnologyinc201253—
+4K121601Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSynthes USA20126—
+4K120854Synthes VA LCP Ankle Trauma SystemSynthes USA201244—
+4K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126—
+4K120360Ortho Solutions Trauma Plates for OsteosysnthesisOrtho Solutions Limited20122—
+4K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Synthes USA201253—
+4K121004Apex Kirschner Wires and Steinmann PinsApex Tools & Orthopedics Co.20122—
+4K120667VLP 2.7MM Extra Large Percutaneous Calcaneus Plate, Peri-Loc 3.5MM Anterior Ankle Fusion…Smith & Nephew, Inc.20129—
+4K120070Synthes Variable Angle LCP Elbow SystemSynthes USA2012761
+4K113762Checkmate Metatarso-Phalangeal (MTP) Arthrodesis SystemArthrosurface, Inc.20121—
+4K112583Synthes Cortical ScrewsSynthes (USA) Products, LLC2011118—
+4K110069Smith & Nephew, Inc Spatialframe V4.1 Web-Based SoftwareSmith & Nephew, Inc.201118—
+5K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical20260—
+5K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…Ortler Global Tibbi Gerecler Anonim Sirketi20260—
+5K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.20260—
+5K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti.20260—
+5K261511Xpert AnkleNewclip Technics20260—
+5K260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.20260—
+5K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+5K261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC20260—
+5K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC20260—
+5K260054I.T.S. PRS Phoenix III.T.S. GmbH20260—
+5K260900DYNEX® External Fixation SystemsVilex, LLC20260—
+5K260274Airlock® Ankle Plating SystemNovastep SAS20260—
+5K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.20261—
+5K253906Xpert HandNewclip Technics20260—
+5K254093DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating SystemSynthes GmbH20260—
+5K260069DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystemSynthes GmbH20260—