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510(k) Data Aggregation

    K Number
    K182970
    Device Name
    EUROPA™ Pedicle Screw System
    Manufacturer
    MiRus, LLC
    Date Cleared
    2019-01-22

    (88 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K082942,K041801,K071495,K041119
    Predicate For
    K191757,K192268
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EUROPA™ Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

    The EUROPA™ Pedicle Screw System is intended for posterior, noncervical pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

    Device Description

    The EUROPA™ Pedicle Screw System is a rigid thoracolumbosacral pedicle screw system as defined in 21 CFR 888.3070. The system is comprised of both Open and Minimally Invasive Surgery (MIS) polyaxial pedicle screw and rod components that are available in different sizes to accommodate various patient anatomical and physiological requirements.

    AI/ML Overview

    The provided text describes a 510(k) submission for a medical device, the EUROPA™ Pedicle Screw System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on studies involving human performance or AI. Therefore, the document does not contain the information required to answer the questions about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies related to AI or human-in-the-loop performance.

    The "Performance Data" section (Section X) explicitly states:
    "The following performance data were provided in support of the substantial equivalence determination.

    • static and dynamic compression bending - ASTM F1717
    • static torsion ASTM F1717 ●"

    This indicates that the performance data provided are for mechanical and material testing of the pedicle screw system, not for clinical performance, diagnostic accuracy, or human-AI interaction.

    Therefore, I cannot extract the requested information from the provided document.

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