BEUDAMED
    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: HWC FDA class 2

    Screw, Fixation, Bone

    Orthopedic

    View full classification →

    A bone fixation screw is a threaded metallic implant used in orthopedic surgery to stabilize bone fractures, attach plates or other hardware to bone, or secure bone grafts and prosthetic components. It is classified as an FDA Class 2 device under 21 CFR 888.3040, indicating moderate risk and requiring 510(k) premarket clearance. Product code HWC falls under the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Eleganz Fusion Screw System (Fusion Screw System)
    TriMed® Compression Screws
    SnapHammer Hammertoe Correction System
    TITANEX Screw Systems
    Caliber Intramedullary Fixation System
    Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
    Arthrex SS VAL and VAL KreuLock™ Compression Screw System
    Locking Screw,CoCrMo
    OsteoCoil™ Nitinol Compression System (Multiple Component PNs)
    Tigon Medical Fractures, Instability, and Reconstruction (FIRE)
    OsteoCentric Technologies Cannulated Fasteners and Nuts
    Treace Medical Concepts (TMC) Screw Fixation System
    Arthrex VAL and VAL KreuLock™ Compression Screw System
    Medline UNITE® MIS Foot Recon Screw System
    OSSIOfiber® Threaded Trimmable Fixation Nail
    Arthrex Cannulated Screw System
    Cannulated Headless Bone Screws
    DynaNail Mini Tapered Hybrid
    ARIX Cannulated Screw System
    OSSIOfiber® Threaded Trimmable Fixation Nails
    SnapHammer Hammertoe Correction System
    TriMed Threaded Intramedullary Nail System
    TDM Screw System
    Zimed Distal Medial Tibial Plate and Screw System
    Cannulated Screw System
    APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension
    MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
    Intraosseous Fusion Device System
    Accelerate 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-L
    TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System
    Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
    Nexis® compressive screws
    IBS-B MIS Beveled Screw System
    Forma Medical Headless Compression Screw
    OsteoCentric ACL Fixation System
    Bone Bolt System
    Cut Screw - Percutaneous Compression Screw
    Acumed Acutrak 3 Headless Compression Screw System
    Hand Trauma Threaded Nail System
    SimpliFix Hip System
    TriMed Threaded Intramedullary Nail System
    REVCON (TM) Screw System
    PROstep(TM) MIS 5mm Chamfer Screw System
    Bony Trauma Extremity System (BTES) Screw Range, NX Nail
    OIC Intramedullary Screw System
    CREED™ Cannulated Screws
    Metal Cannulated Screw
    Haymaker® Screw System
    Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
    OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump