LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K013072
    Device Name
    CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)
    Manufacturer
    SYNTHES
    Date Cleared
    2002-11-26

    (439 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP)

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

    Synthes chronOS is intended for use as a bone void filler in voids or gaps that are not intrinsic to the stability of the bony structure. chronOS is indicated for use in the treatment of bony defects created surgically or through traumatic injury.

    chronOS is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine, and pelvis). Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

    Device Description

    Synthes chronOS is a porous, osteoconductive, resorbable bone void filler made from β-Tricalcium Phosphate (TCP). chronOS features a uniform three dimensional pore structure. Pore diameters within the material range from 100 to 500 µm. chronOS is provided sterile in granules and preformed shapes (e.g. blocks, cylinders, wedges).

    chronOS may be packaged with a perfusion syringe that is used to mix the bone void filler with the patient's blood components.

    AI/ML Overview

    This 510(k) premarket notification for Synthes chronOS, a bone void filler, does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is primarily focused on establishing substantial equivalence to predicate devices for regulatory clearance.

    Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

    The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, meaning that the FDA determined it is as safe and effective as existing devices. This type of regulatory submission typically relies on comparisons to well-established devices rather than extensive new clinical performance studies with specific acceptance criteria that would be detailed in the submission.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1