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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
    AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
    Precice™ Max System and Precice™ Ankle Salvage System
    Fule Metallic Lockable Intramedullary Nail Systems
    HERA Interlocking Intramedullary Nailing System
    FITBONE® TRANSPORT AND LENGTHENING SYSTEM
    Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
    AUTOBAHN™ Nailing System
    Arthrex Humeral Nails
    Fusion FibFix Nail
    Affixus Retrograde Femoral Nailing System
    Reselute Tibial Nail
    Phantom® Hindfoot TTC/TC Nail System
    Arthrex FibuLock Nail System
    Active Intramedullary (AIM) Tibial Nail System
    T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
    Affixus® Natural Nail® Proximal Humeral System
    ARIX Femur Nail System
    Estremo Fibular Nail
    DynaNail TTC Fusion System
    T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
    T2 Alpha Femur Retrograde Nailing System
    Succession™ AFN System
    Phantom® Hindfoot TTC/TC Nail System
    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

    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
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