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510(k) Data Aggregation

    K Number
    K043280
    Device Name
    MIMIX MP BONE VOID FILLER
    Manufacturer
    BIOMET, INC.
    Date Cleared
    2004-12-21

    (25 days)

    Product Code
    GXP
    Regulation Number
    882.5300
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    K990290
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Mimix™ MP Bone Void Filler is a self-setting calcium phosphate cement indicated for the following craniofacial procedures:

    1. Repair of neurosurgical burr holes
    2. Craniotomy cuts and other cranial defects
    3. Augmentation or restoration of bony contour in the craniofacial skeleton area no larger than 25cm².
    Device Description

    The Mimix™ MP Bone Void Filler is packaged as separate, pre-measured powder and liquid components. These are intended to be mixed intraoperatively to produce a homogenous paste, which then sets into a hard, porous material. Because of its apatitic nature, the material is highly biocompatible. The powder component is a mixture of a ceramic calcium phosphate powder and sodium phosphate. The liquid component is a solution comprised of anhydrous citric acid (C6H8O7) and water (H2O).

    AI/ML Overview

    The provided text is a 510(k) summary for the "Mimix™ MP Bone Void Filler" and explicitly states:

    "Clinical Testing: Clinical testing was not used to establish substantial equivalence."

    Therefore, a study demonstrating the device meets acceptance criteria was not performed for this submission. The 510(k) relies on substantial equivalence to a predicate device (Mimix™ Bone Void Filler K990290) based on non-clinical testing.

    As such, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies for a clinical study that did not occur.

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