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    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: HSB FDA class 2

    Rod, Fixation, Intramedullary And Accessories

    Orthopedic

    View full classification →

    An intramedullary rod and accessories system is a set of surgically implanted metallic rods and associated components inserted into the medullary canal of long bones to stabilize and align fractures during healing. It is classified as an FDA Class 2 device under 21 CFR 888.3020, indicating moderate risk and requiring 510(k) premarket clearance. Product code HSB falls under the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    GMReis Fibula Nail System
    ARIX Femur Nail System
    FitboneTM Trochanteric
    Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur
    Fassier-Duval Telescoping IM System
    Affixus Tibial Nailing System - 4mm screws
    Arthrex Intramedullary Nails
    TRIGEN META-TAN Trochanteric Antegrade Nail
    Atlas™ Humeral Nail System
    Affixus Tibial and Antegrade Femoral Nailing System
    Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System
    Phantom Fibula Nail System
    DePuy Synthes Retrograde Femoral Nail Advanced System
    Fitbone Trochanteric
    RODEO Telescopic Nail
    Vertex Hip Fracture Nailing System
    FITBONE® Transport and Lengthening System
    I.T.S. INS Proximal Femur Nail
    Flow-Nail
    Redemption Duo Hindfoot Nail System
    Precice Max System
    Tornier Humeral Nail and Tornier Long Humeral Nail
    Precice Ankle Salvage System
    Pediatric Nailing Platform Tibia
    Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System
    Arthrex Intramedullary Nails
    SGM Femoral Nail System
    Gamma4 System
    Precice Intramedullary Limb Lengthening System
    Pro-X1™ Trochanteric Nailing System
    Dyna Locking Trochanteric Nail™
    Advanced Intramedullary Nail System
    Arthrex DualCompression Hindfoot Fusion Nail Implant System
    Femoral Trochanteric Nail System – Neonail
    Flex-Thread™ Ulna Intramedullary Nail System
    Gamma4 System
    Smith & Nephew Intramedullary Nail Systems
    Artemis Proximal Femoral Nail System
    AUTOBAHN(R) EVO Femoral Nails
    Pediatric Nailing Platform Femur
    Flow-Nail
    Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
    GPC Intraheal Intramedullary Nailing System
    The Progen™ Trochanteric Nail System
    Flex-Thread™ Distal Fibula lntramedullary Nail System
    Elos® Intramedullary Nailing System
    Phantom Hindfoot TTC/TC Nail System
    Fassier-Duval Telescopic IM System
    Adaptable Ortho Innovations Intramedullary Nail System
    T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System

    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.

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