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510(k) Data Aggregation

    K Number
    K083232
    Device Name
    MODIFICATION TO:MICROFUSE BONE VOID FILLER
    Manufacturer
    GLOBUS MEDICAL INC.
    Date Cleared
    2008-12-24

    (51 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K071187,K082442
    Why did this record match?
    Device Name :

    MODIFICATION TO:MICROFUSE BONE VOID FILLER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MicroFuse™ Bone Void Filler, combined with autograft or bone marrow aspirate, is intended for use in filling bony voids or gaps of the extremities, spine and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. MicroFuse™ provides a bone void filler that resorbs and is replaced with bone during the healing process.

    Device Description

    MicroFuse™ Bone Void Filler is a porous bone graft scaffold composed of bonded poly (lactide-co-glycolide) or poly(lactic acid) microspheres. MicroFuse™ is available with and without a combination of barium sulfate and calcium sulfate. MicroFuse™ is provided in a variety of shapes and sizes, in the form of granules, sheets, and pre-formed blocks. MicroFuse™ granules are designed to be gently packed into contained voids or defects. MicroFuse™ sheets are designed to be used with shallow bony defects, or as a bone graft onlay to cover a defect. MicroFuse™ blocks are designed to fill an entire defect. MicroFuse™ implants are available in short-term (ST), mid-term (MT), or long-term (LT) compositions.

    AI/ML Overview

    The provided text is a 510(k) summary for the MicroFuse™ Bone Void Filler, which details the device's description, intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

    A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a performance study with specific acceptance criteria as might be found in a PMA (Pre-Market Approval) application or a clinical trial report for drug approval.

    Therefore, I cannot provide the requested information based on the input text. The document confirms that the device was found substantially equivalent to predicate devices, allowing it to be marketed, but it does not detail specific performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to a performance study.

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