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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: HRS FDA class 2

    Plate, Fixation, Bone

    Orthopedic

    View full classification →

    A bone fixation plate is a metallic implant used in orthopedic surgery to stabilize and hold fractured or osteotomized bone segments in position during the healing process. It is classified as an FDA Class 2 device under 21 CFR 888.3030, indicating moderate risk and requiring 510(k) premarket clearance. Product code HRS falls under the Orthopedic medical specialty. This device is an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)
    Genostis Osteosynthesis System
    Equinoxe® Scapula Fracture System
    TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm)
    LORRAINE 2.5/3.5mm Distal Humerus System
    Montblanc Plate System
    ARIX Pectus Bar System
    SIGNEX
    TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw)
    Pediatric Plating Platform Hip
    CastleLoc Pectus Bar System
    CanMINI Hand and Foot System
    Xpert Knee
    TriMed Fusion Cup System
    Arthrex Humeral Plating System and Cerclage Button
    Tyber Medical Anatomical Plating System
    TriMed Elbow and Forearm System
    TriMed Ankle Fixation System
    The OsteoCentric Bone Plate and Screw System
    BPS Wrist Fracture System
    APTUS Hand System; APTUS Elbow Dorsal Olecranon
    CastleLoc Pectus Bar System
    EVOS Pelvic and Acetabular System
    A.L.P.S. Small Fragment Plating System
    Locking Plates and Screws Systems
    BPS - Bone Fragment Fixation Plates, Screws and Washers
    Signature Osteosynthesis Plate System
    Versalock Upper Limb Plating System
    TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs);
    ARTFX Trauma Bone Plate and Screw System
    Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
    SternalPlate Expansion
    TDM Plate and Screw System
    TriMed Posterior Malleolus Fixation System
    HyperFlex™ Bunion Correction System
    GMReis Ankle Plating System
    Versalock Mini and Micro Plating System
    Proximal Humerus Fixation System
    Arthrex Elbow Fracture Plating System
    Tandry Q-Locking Plate System
    Osteotomy Truss System (OTS)
    Bonebridge Osteosynthesis Plating System
    OIC Small / Mini Fragment Plate System
    Arthrex VAL and VAL KreuLock™ Compression Screw System
    Clavicle and Scapula System
    Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System
    BPS Wrist Fracture System
    Protean Fragment Plating System
    Pectus Blu Support Bar System
    TriMed Bridge Plates

    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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