Orthopedic

HWC · Screw, Fixation, Bone

Orthopedic · 21 CFR 888.3040 · Class 2

Overview

Product CodeHWC
Device NameScrew, Fixation, Bone
Regulation21 CFR 888.3040
Device ClassClass 2
Review PanelOrthopedic
ImplantYes

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Classification Rationale

Class II.

Cleared Devices (1054)

RecordDevice NameApplicantDecision DateDecision
K260934TITAN Nail; APTUS K-Wire SystemMedartis AGApr 17, 2026SESE
K252699CoAptix S SystemUniversity of Utah, Department of OrthopaedicsApr 10, 2026SESE
K253042Tyber Medical Trauma ScrewTyber Medical, LLCApr 3, 2026SESE
K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QuattroMedShape, Inc.Mar 18, 2026SESE
K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.Mar 6, 2026SESE
K252901Tyber Medical Trauma ScrewTyber Medical, LLCDec 31, 2025SESE
K251555Ultra™ Compression Screw SystemPace SurgicalNov 6, 2025SESE
K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev4Oct 10, 2025SESE
K250536MetaFore Small Screw SystemExtremity Medical, LLCOct 8, 2025SESE
K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.Oct 2, 2025SESE
K252019CurvaFix Low Profile SystemCurvafix, Inc.Aug 29, 2025SESE
K251382Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc.Aug 27, 2025SESE
K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLCAug 15, 2025SESE
K250251Eleganz Fusion Screw System (Fusion Screw System)Dev4Jun 13, 2025SESE
K243943TriMed® Compression ScrewsTriMed, Inc.Apr 10, 2025SESE
K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.Apr 2, 2025SESE
K250304TITANEX Screw SystemsVilex, LLCMar 5, 2025SESE
K242896Caliber Intramedullary Fixation SystemNvision Biomedical TechnologiesFeb 5, 2025SESE
K242442Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewInnovate Orthopaedics, Ltd.Jan 31, 2025SESE
K243195Arthrex SS VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.Jan 10, 2025SESE
K242348Locking Screw,CoCrMoDouble Medical Technology, Inc.Dec 4, 2024SESE
K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower OrthoNov 22, 2024SESE
K240175Tigon Medical Fractures, Instability, and Reconstruction (FIRE)Tigon MedicalOct 29, 2024SESE
K242691OsteoCentric Technologies Cannulated Fasteners and NutsOsteoCentric TechnologiesOct 9, 2024SESE
K242671Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.Oct 4, 2024SESE
K241592Arthrex VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.Aug 31, 2024SESE
K241359Medline UNITE® MIS Foot Recon Screw SystemMedline Industries, LPAug 2, 2024SESE
K241277OSSIOfiber® Threaded Trimmable Fixation NailOSSIO , Ltd.Jul 3, 2024SESE
K240815Arthrex Cannulated Screw SystemArthrex, Inc.Jun 13, 2024SESE
K233008Cannulated Headless Bone ScrewsAap Implantate AGJun 5, 2024SESE
K240530DynaNail Mini Tapered HybridMedShape, Inc.Mar 21, 2024SESE
K233912ARIX Cannulated Screw SystemJeil Medical CorporationMar 11, 2024SESE
K233198OSSIOfiber® Threaded Trimmable Fixation NailsOSSIO , Ltd.Mar 8, 2024SESE
K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc.Feb 16, 2024SESE
K234040TriMed Threaded Intramedullary Nail SystemTriMed, Inc.Jan 18, 2024SESE
K231860TDM Screw SystemTdm Co., Ltd.Jan 18, 2024SESE
K230507Zimed Distal Medial Tibial Plate and Screw SystemZimed MedikalJan 4, 2024SESE
K233396Cannulated Screw SystemSmith & Nephew, Inc.Dec 21, 2023SESE
K232251APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line ExtensionMedartis AGNov 3, 2023SESE
K231231MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation DevicesParagon 28, Inc.Oct 12, 2023SESE
K231649Intraosseous Fusion Device SystemAuxano Medical, LLCSep 29, 2023SESE
K230946Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-LTrax SurgicalSep 15, 2023SESE
K231504TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw SystemVilex, LLCSep 11, 2023SESE
K231819Quick-Start Orthopaedic Fixation Screw and Reverse Thread ScrewInnovate Orthopaedics LimitedSep 5, 2023SESE
K223468Nexis® compressive screwsNovastepAug 30, 2023SESE
K231236IBS-B MIS Beveled Screw SystemIn2bones USA, LLCJul 27, 2023SESE
K230945Forma Medical Headless Compression ScrewForma Medical, Inc.Jul 18, 2023SESE
K230595OsteoCentric ACL Fixation SystemOsteoCentric TechnologiesJun 29, 2023SESE
K230867Bone Bolt SystemUniversity of Utah, Department of OrthopaedicsJun 26, 2023SESE
K230397Cut Screw - Percutaneous Compression ScrewGM Dos Reis Industria e Comercio Ltda.Jun 12, 2023SESE
K230744Acumed Acutrak 3 Headless Compression Screw SystemAcumed, LLCJun 9, 2023SESE
K230908Hand Trauma Threaded Nail SystemSkeletal Dynamics, Inc.Apr 28, 2023SESE
K230053SimpliFix Hip SystemStabiliz Orthopaedics, Inc.Apr 19, 2023SESE
K230749TriMed Threaded Intramedullary Nail SystemTriMed, Inc.Apr 17, 2023SESE
K223392REVCON (TM) Screw SystemVoom Medical Devices, Inc.Feb 28, 2023SESE
K221645PROstep(TM) MIS 5mm Chamfer Screw SystemWright Medical TechnologyFeb 17, 2023SESE
K230118Bony Trauma Extremity System (BTES) Screw Range, NX NailField Orthopaedics Pty, Ltd.Feb 16, 2023SESE
K223761OIC Intramedullary Screw SystemOrthopaedic Implant CompanyFeb 13, 2023SESE
K223847CREED™ Cannulated ScrewsGlw, Inc.Jan 25, 2023SESE
K222799Haymaker® Screw SystemOrthocircle Spine D.B.A. OC Medical DevicesJan 10, 2023SESE
K221090Metal Cannulated ScrewDouble Medical Technology, Inc.Jan 10, 2023SESE
K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR ConditionalAcumed, LLCDec 29, 2022SESE
K221193OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mmOSSIO , Ltd.Dec 23, 2022SESE
K223184Phantom Metatarsal Shortening SystemParagon 28, Inc.Dec 16, 2022SESE
K222820BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm ExtremitiesDec 16, 2022SESE
K221342REDEMPTION Beaming SystemVilex, LLCDec 13, 2022SESE
K220921Metal Bone ScrewDouble Medical Technology, Inc.Dec 12, 2022SESE
K222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated ScrewsAvanti Orthopaedics, Inc.Nov 23, 2022SESE
K222564Treace Medical Concepts (TMC) Hammertoe Fixation SystemTreace Medical Concepts, Inc.Nov 15, 2022SESE
K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.Nov 4, 2022SESE
K222505CurvaFix IM SystemCurvafix, Inc.Oct 27, 2022SESE
K220359Tandry Compression Screw SystemMicroware Precision Co., Ltd.Sep 20, 2022SESE
K220839Arthrex Compression FT PinsArthrex, Inc.Sep 19, 2022SESE
K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.Sep 8, 2022SESE
K213614Cannulated ScrewsMaxxion Medical, LLCAug 3, 2022SESE
K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbHJun 10, 2022SESE
K220723Hand Trauma Screw SystemSkeletal Dynamics, Inc.May 12, 2022SESE
K220892ExsoMed INnate NanoTM Lag Screw SystemExsomed Corp.Apr 27, 2022SESE
K210146Cannulated Compression Device SystemOrthopedic Designs North America, Inc.Apr 13, 2022SESE
K220511Medline UNITE IM Fibula ImplantMedline Industries, LPMar 22, 2022SESE
K212755SIGNUS SACRONAIL® Transsacral Stabilization SystemSignus Medizintechnik GmbHMar 10, 2022SESE
K203335MectaScrew ExtensionMedacta International S.A.Feb 3, 2022SESE
K211628MIS Precision Chevron Bunion SystemRelja Innovations, LLCJan 31, 2022SESE
K213572JuniOrtho Plating System™Orthofix SrlJan 18, 2022SESE
K203773BRM TOOL ScrewsBrm Extremities SrlJan 14, 2022SESE
K213199Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw SystemStryker GmbHJan 11, 2022SESE
K203595DynaFuse Fixation SystemMedShape, Inc.Jan 4, 2022SESE
K212547Quick-Start ScrewsInnovate Orthopaedics LimitedDec 30, 2021SESE
K211770R3ACT Stabilization SystemParagon 28, Inc.Dec 25, 2021SESE
K213596OSSIOfiber Compression Screw, 3.5mmOSSIO , Ltd.Dec 21, 2021SESE
K213301InCore Subtalar SystemNextremity Solutions, Inc.Dec 21, 2021SESE
K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.Dec 9, 2021SESE
K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.Nov 19, 2021SESE
K212996Sterile PHALINX Hammertoe SystemWrightmedicaltechnologyincNov 16, 2021SESE
K202326BESPA Charcot SystemBespa Global, LLCNov 9, 2021SESE
K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.Oct 21, 2021SESE
K210490ChM 4.5mm Cortical screwsChm Sp. Z O.O.Oct 5, 2021SESE
K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.Sep 23, 2021SESE
K210792Auxein Nailing SystemAuxein Medical Private LimitedAug 25, 2021SESE
K203029Auxilock Titanium Interference ScrewAuxein Medical Private LimitedAug 20, 2021SESE
K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.Aug 6, 2021SESE
K211435PAO Cortical ScrewMedacta International S.A.Aug 6, 2021SESE
K211290Cannulated Fasteners and NutsOsteoCentric TechnologiesAug 3, 2021SESE
K210159IntraLock SystemFusion Orthopedics, LLCJul 23, 2021SESE
K211944Medline UNITE® Digital Fusion Screw SystemMedline Industries, Inc.Jul 22, 2021SESE
K210994Arthrex Beveled FT ScrewsArthrex, Inc.Jun 1, 2021SESE
K211261Axis Charcot Fixation SystemExtremity Medical, LLCMay 28, 2021SESE
K203228DART-FIRE EDGE Cannulated Screw SystemWright MedicalMay 11, 2021SESE
K210754Cannulated Fasteners and NutsOsteoCentric TechnologiesApr 14, 2021SESE
K210268LTJ Screws and WasherAzurmeds, Inc.Feb 26, 2021SESE
K203381Dynanail Mini HybridMedShape, Inc.Jan 15, 2021SESE
K203105Inion CompressOn ScrewInion OYJan 13, 2021SESE
K193497Fixone Biocomposite Interference ScrewAju Pharm Co., Ltd.Jan 5, 2021SESE
K203239Arthrex Low Profile ScrewsArthrex, Inc.Dec 30, 2020SESE
K203467WishBone Medical Plate and Screw SystemWishbone Medical, Inc.Dec 23, 2020SESE
K200291CREED™ Cannulated ScrewsGlw Medical, Inc.Dec 16, 2020SESE
K203011Monster Screw SystemParagon 28, Inc.Nov 13, 2020SESE
K202589APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire SystemMedartis AGNov 6, 2020SESE
K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLCOct 22, 2020SESE
K202680OsteoMed ExtremiFix Mini & Small Cannulated Screw SystemOsteomed, LLCOct 15, 2020SESE
K202569Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLCSep 23, 2020SESE
K200987LTJ Screws and WasherAzurmeds, Inc.Sep 22, 2020SESE
K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.Aug 4, 2020SESE
K193660OSSIOfiber™ Compression ScrewsOSSIO , Ltd.Jul 30, 2020SESE
K201662REDUCT® Headless Compression Screw SystemSkeletal Dynamics, Inc.Jul 16, 2020SESE
K201556Intraosseous Fixation SystemExtremity Medical, LLCJul 8, 2020SESE
K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc.Jun 26, 2020SESE
K200226RetroFixRetrofix Screws, LLCJun 26, 2020SESE
K201430InFrame™ Cannulated Fixation SystemExsomed Corp.Jun 20, 2020SESE
K201319Medline UNITE Jones Fracture Screw SystemMedline Industires, Inc.Jun 17, 2020SESE
K200124InCore MPJ SystemNextremity Solutions, Inc.May 13, 2020SESE
K200914Healix Compression Screw SystemNvision Biomedical Technologies, Inc.May 5, 2020SESE
K200259Headless Compression Screw SystemOsteocentric Extremities, LLCMay 4, 2020SESE
K191995S4 Screw SystemSubchondral Solutions, Inc.Apr 18, 2020SESE
K193366T2 ICFStryker GmbHMar 20, 2020SESE
K193491restor3d Metallic Interference ScrewRestor3DMar 19, 2020SESE
K192096Omnia Medical Trauma ScrewsOmnia Medical, LLCFeb 27, 2020SESE
K193451Titanium Interference ScrewsBiomet, Inc.Feb 24, 2020SESE
K193156Arthrex Mini Comprehensive Fixation System - 1.0mm ScrewsArthrex, Inc.Feb 10, 2020SESE
K192975Tyber Medical Trauma ScrewsTyber Medical, LLCJan 9, 2020SESE
K192974Tyber Medical Trauma ScrewTyber Medical, LLCJan 8, 2020SESE
K192578InCore TMT SystemNextremity Solutions, Inc.Dec 31, 2019SESE
K192745DePuy Synthes Trauma ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.Nov 26, 2019SESE
K192417ARIX Cannulated Screw SystemJeil Medical CorporationNov 26, 2019SESE
K191651Arthrex Nano SwiveLock Suture AnchorArthrex, Inc.Nov 6, 2019SESE
K190921Arthrex Low Profile ScrewsArthrex, Inc.Oct 30, 2019SESE
K191771SECURE ScrewA.M. Surgical, Inc.Oct 16, 2019SESE
K190830TDM Screw SystemsTdm Co., Ltd.Sep 13, 2019SESE
K191424Interphalangeal Joint Fusion Device RangeNeosteoAug 28, 2019SESE
K191342CrossRoads Screw SystemCrossroads Extemity Systems, LLCAug 19, 2019SESE
K190970PROSTEP™ TBI™ (Tailors Bunion Implant) SystemWrightmedicaltechnologyincAug 13, 2019SESE
K191289Bone Screw Line AdditionVilex IN Tennessee, Inc.Jul 29, 2019SESE
K191817ActivOrtho Continuous Compression Screw SystemActivortho, Inc.Jul 26, 2019SESE
K190324OrthoPediatrics Cannulated Screw SystemOrthoPediatrics Corp.Jul 5, 2019SESE
K183363Treace Medical Concepts (TMC) Snap-Off Screw SystemTreace Medical Concepts, Inc.Jun 13, 2019SESE
K183104Mini Cannulated Headed and Headless Screw SetStryker GmbHJun 10, 2019SESE
K190231InCore® Lapidus Sterile KitsNextremity Solutions, Inc.May 24, 2019SESE
K182342IntraLock Lapidus SystemFusion Orthopedics, LLCMay 21, 2019SESE
K183395Arthrex 2.5 mm Tenodesis ScrewArthrex, Inc.Apr 17, 2019SESE
K190586Monster® Screw SystemParagon 28, Inc.Apr 3, 2019SESE
K183628Arthrex TensionLoc SystemArthrex, Inc.Mar 26, 2019SESE
K190430OsteoCentric Bone Plate and Screw SystemOsteocentric TraumaMar 22, 2019SESE
K183026Wright Jones Fracture SystemWrightmedicaltechnologyincMar 13, 2019SESE
K183603INnate Cannulated Screw SystemExsomed CorporationMar 12, 2019SESE
K181610ActivOrtho Nitinol Compression Screw SystemActivortho, Inc.Mar 12, 2019SESE
K180050CurvaFix Intramedullary Rodscrew SystemCurvafix, Inc.Mar 1, 2019SESE
K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLCFeb 19, 2019SESE
K182677DynaNail MiniMedShape, Inc.Feb 14, 2019SESE
K190035Biomet Headless Compression and Twist-Off ScrewsBiomet, Inc.Feb 7, 2019SESE
K182955EZStart Interference ScrewConmed CorporationJan 22, 2019SESE
K181377PROSTEP MICA Screw SystemWrightmedicaltechnologyincJan 11, 2019SESE
K182989AURORA™ Screw SystemMiRus, LLCDec 18, 2018SESE
K182361Arthrex Compression FT ScrewsArthrex, Inc.Dec 18, 2018SESE
K180670ICONN Campbell Interference ScrewIconn Orthopedics, LLCDec 7, 2018SESE
K182949Healix™ Compression Screw SystemNvision Biomedical Technologies, LLCDec 4, 2018SESE
K182684HammerTechTM Fixation SystemFusion Orthopedics, LLCNov 23, 2018SESE
K180573Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLCNov 23, 2018SESE
K180541DePuy Synthes 2.0 mm Quick Insertion ScrewsSynthes USA Products, LLCNov 21, 2018SESE
K181898Two-Step Implant SystemTrilliant SurgicalOct 26, 2018SESE
K182148SILVERBACK Gorilla Plating SystemParagon 28, Inc.Sep 7, 2018SESE
K180348Field Orthopaedics Micro Screw SystemField Orthopaedics Pty, Ltd.Jul 17, 2018SESE
K173556Injection ScrewBiedermann Medtech, Inc.Jul 13, 2018SESE
K180024SALVATION Midfoot NailWrightmedicaltechnologyincJul 11, 2018SESE
K180377Fracture and Correction SystemIn2bones USA, LLCJun 20, 2018SESE
K180500VariAx 2 SystemStryker GmbHJun 4, 2018SESE
K180932Diamond Orthopedic Bone Fixation Screws and PinsDiamond Orthopedic, LLCMay 9, 2018SESE
K180257InCore® Lapidus SystemNextremity Solutions, Inc.Apr 25, 2018SESE
K180753SafetyFix EasyOut SystemSafetyfix Medical Technologies, Inc.Apr 20, 2018SESE
K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLCFeb 12, 2018SESE
K172698G-Beam Fusion Beaming SystemOrthofix SrlFeb 7, 2018SESE
K171628HBS2 Headless Bone ScrewStuckenbrock Medizintechnik GmbHJan 12, 2018SESE
K172383Arthrosurface Bone ScrewsArthrosurface, Inc.Dec 22, 2017SESE
K173286Cannulated Screw Internal Fixation SystemLife Spine, Inc.Dec 14, 2017SESE
K170688PIT’Stop® implantIn2bones SasNov 28, 2017SESE
K173135VariAx 2 SystemStryker GmbHNov 27, 2017SESE
K172617Treace Medical Concepts (TMC) Compression Screw SystemTreace Medical Concepts, Inc.Oct 25, 2017SESE
K172213MECRON Cannulated Screw SystemMerete GmbHOct 23, 2017SESE
K170056IRENE Cannulated Screw SystemTianjin Zhengtian Medical Instrument Co., Ltd.Oct 23, 2017SESE
K172596Large Screws RangeNewclip TechnicsOct 2, 2017SESE
K163148BePOD® Foot ScrewsFournitures Hospitalieres IndustrieSep 14, 2017SESE

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