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510(k) Data Aggregation

    K Number
    K250216
    Device Name
    OsteoProbe (OP-100)
    Manufacturer
    Active Life Scientific, Inc.
    Date Cleared
    2025-09-11

    (230 days)

    Product Code
    QGQ
    Regulation Number
    888.1600
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K221195
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OsteoProbe is a measurement tool intended to assess bone tissue resistance to microindentation on the tibia of adults, reported as the Bone Material Strength Index (BMSi). In laboratory studies, BMSi measurements have been shown to correlate with biomechanical properties of bone, including whole-bone strength and fracture toughness. The clinical significance of laboratory-based biomechanical studies is unknown. The device is not intended to diagnose disease, predict fracture risk, or treat any clinical condition. Prescription use only, by or on the order of a physician.

    Device Description

    OsteoProbe is a bone microindentation device. It is a prescription device per 21 CFR Part 801.109. The device includes a single-use disposable component and reusable components. The single-use disposable component has a Spaulding classification of critical and is provided sterile. The reusable components have a Spaulding classification of non-critical and must be reprocessed (cleaning and intermediate-level disinfection) between each use. The device has one accessory: a single-use, disposable sterile cover.

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