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510(k) Data Aggregation

    K Number
    K012486
    Device Name
    OSTEOMED BIORESORBABLE FIXATION SYSTEM
    Manufacturer
    OSTEOMED CORP.
    Date Cleared
    2002-01-16

    (167 days)

    Product Code
    DZL,JEY
    Regulation Number
    872.4880
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K972913,K974554,K993061
    Why did this record match?
    Device Name :

    OSTEOMED BIORESORBABLE FIXATION SYSTEM

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

    Indicated for use in trauma and reconstructive procedures in the midface and craniofacial skeleton, including, but not limited to, comminuted fractures of the nasoethmoidal and infraorbital areas, comminuted fractures of the frontal sinus wall and midfacial fractures, and reconstructive procedures of the midface or craniofacial skeleton. The OsteoMed Bioresorbable Fixation System is not intended for use in and is contraindicated for: the mandible and/or full load bearing procedures; in cases of active or suspected infection or in patients who are immunocompromised; in cases where there is limitation of the blood supply or inadequate volume or quality of bone to place the system securely; in patients exhibiting disorders which would cause the patient to ignore the limitations of rigid fixation.

    Device Description

    The OsteoMed Bioresorbable Fixation System is comprised of various plates, meshes and screws. Plates and meshes, 0.5mm through 1.2mm thick, are provided in various shapes and sizes. Screws are provided in 1.6mm diameter in lengths of 4.0mm through 8.0mm. Safety screws are 2.0mm diameter in lengths of 4.0mm through 8.0mm. The implanted components of the device are manufactured from 70:30 poly L/D,L-lactide.

    AI/ML Overview

    The provided 510(k) summary for the OsteoMed Bioresorbable Fixation System does not contain information about acceptance criteria or a study proving the device meets said criteria.

    Instead, this document focuses on establishing substantial equivalence to previously cleared devices based on similarities in intended use, material, design, and operational principle.

    Therefore, I cannot provide the requested information from the given text.

    Specifically, the document lacks information on:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for a test set, data provenance, or details about a study.
    3. Number of experts, their qualifications, or ground truth establishment for a test set.
    4. Adjudication method for a test set.
    5. MRMC comparative effectiveness study or effect size.
    6. Standalone performance study.
    7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a specific study.
    8. Sample size for a training set.
    9. How ground truth for a training set was established.
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