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510(k) Data Aggregation

    K Number
    K252661

    Validate with FDA (Live)

    Device Name
    SternaFuse Ti Fixation System
    Manufacturer
    Fusion Innovations, LLC
    Date Cleared
    2025-11-19

    (89 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K202914,K111908
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SternaFuse Ti Fixation System is indicated for use in the stabilization and fixation of fractures of the anterior chest wall or sternum, including sternal fixation following sternotomy, sternal fractures, and sternal reconstructive surgical procedures to promote fusion. The system is intended for use in patients with normal and/or poor bone quality. The device is for prescription use only.

    Device Description

    The SternaFuse Ti Fixation System implants are manufactured from titanium alloy (Ti6AL-4V ELI) Per ASTM F136 implant quality titanium plates, and screws intended to stabilize and fixate fractures of the anterior chest wall. The components include various sizes to facilitate customization according to the requirements of the anterior chest wall repair. Self-drilling locking screws come in 3.5mm diameter, and lengths of 10mm, 12mm,14mm,16mm,18mm and 20mm. Multiple plates may be used in one anterior chest wall repair.

    All implants are provided non-sterile. The implants should never be reused under any circumstance.

    AI/ML Overview

    N/A

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