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510(k) Data Aggregation

    K Number
    K180337
    Device Name
    EUROPA Pedicle Screw System
    Manufacturer
    MiRus, LLC
    Date Cleared
    2019-03-14

    (400 days)

    Product Code
    NKB,MNH,MNI
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K041119,K041801,K071495,K082942
    Predicate For
    K191757,K192268,K242516
    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.

    The pedicle screws are available in 5 different diameters from Ø4.5mm to Ø8.5mm, are solid or cannulated with lengths ranging from 25mm to 80mm, and are manufactured from Ti-6Al-4V ELI alloy (ASTM F136-13). The rods are Ø4.5mm in diameter with lengths ranging from 30mm to 300mm, are available in both straight or curved configurations to accommodate Open and MIS applications, and are manufactured from Molybdenum-47.5Rhenium alloy (MoRe®, ASTM F3273-17).

    The pedicle screws and rods are intended to be implanted via a posterior approach. Implants are single use and the system is provided non-sterile.

    AI/ML Overview

    This is a 510(k) summary for a medical device called the EUROPA™ Pedicle Screw System, which is a thoracolumbosacral pedicle screw system. The document states that performance data was provided in support of the substantial equivalence determination to a predicate device.

    However, the provided text does not contain information about:

    1. Acceptance criteria and reported device performance in a table. The document lists the types of tests performed (Biocompatibility, Mechanical, Corrosion) but does not provide specific acceptance criteria or the numerical results of these tests.
    2. Sample size used for the test set and data provenance.
    3. Number of experts used to establish ground truth and their qualifications.
    4. Adjudication method.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Standalone (algorithm only) performance. The device described is a physical implant, not an algorithm.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How the ground truth for the training set was established.

    The document primarily focuses on the regulatory aspects of the device, its indications for use, and a comparison to a predicate device. It briefly mentions performance data (biocompatibility, mechanical, corrosion testing) but does not detail the results or the methodology for proving acceptance criteria related to these tests.

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