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510(k) Data Aggregation

    K Number
    K252312
    Device Name
    Eleganz IM Threaded Nail System (IM Threaded Nail System)
    Manufacturer
    Dev4
    Date Cleared
    2025-10-10

    (78 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K230744,K120493,K183603
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Eleganz™ IM Threaded Nail System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, and bunionectomies.

    The nails are not intended for interference or soft tissue fixation.

    Device Description

    The Eleganz™ IM Threaded Nail System includes nails for bone fixation and a set of instruments used for nail site preparation and delivery. The device is offered in one non-sterile tray that contains the nails, Kirschner wire, bone preparation instrumentation and drivers.

    The nails are used to stabilize a fracture, osteotomy site, or joint so that healing and fusion may occur which achieves its intended function.

    The nails are made from 316L stainless steel. They range from 11-75 mm in length.

    The instrumentation includes a reamer, driver handle, driver bit, depth gauge, countersink, and Kirschner wire. The drills and driver components are cannulated. The driver handle is used with the driver bit to insert the screw as well as with the reamer for hand reaming. The countersink has cutting flutes to ease entry of the nails into the intramedullary canal.

    AI/ML Overview

    N/A

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