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510(k) Data Aggregation

    K Number
    K121302
    Device Name
    BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
    Manufacturer
    BIOMET MICROFIXATION
    Date Cleared
    2012-09-19

    (141 days)

    Product Code
    HRS,87H
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K011076,K110574,K111908
    Predicate For
    K142484,K142823,K151019,K161896,K181806,K183172,K202889,K210290
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor bone quality.

    Device Description

    The Biomet Microfixation Sternal Closure System (sometimes abbreviated SL) of plates, including the SternaLock Blu system, is made up of plates of varying shapes currently including, but not limited to, X plates, box plates, straight plates, and L plates. The plates have at least one cuttable cross section, but not more than 4 of these sections when they are intended to cross a non-transverse fracture or sternotomy. There are plates without cuttable cross sections to assist in the fixation of transverse fractures. The plates accept screws with a diameter of 2.4mm and 2.7mm. Self-drilling screws have a maximum length of 20mm. The tip of the selfdrilling screw is designed so that a predrilled hole is not required, but may be used.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (Biomet Microfixation Sternal Closure System) and does not contain information about acceptance criteria and a study proving a device meets them.

    Instead, it's a regulatory document demonstrating substantial equivalence to previously cleared devices. It describes the device, its intended use, materials, possible risks, and details related to its design, which are similar to existing devices.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC study, standalone performance), or ground truth establishment.

    The document primarily focuses on establishing similarity to predicate devices rather than presenting the results of a performance study against specific acceptance criteria.

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