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510(k) Data Aggregation

    K Number
    K131427

    Validate with FDA (Live)

    Device Name
    LOTUS
    Manufacturer
    SPINAL ELEMENTS, INC.
    Date Cleared
    2013-10-24

    (160 days)

    Product Code
    KWP,MNH,MNI
    Regulation Number
    888.3050
    Type
    Traditional
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K120467
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System is intended for posterior fixation of the cervical and thoracic spine (C1-T3) for the following conditions: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies): spondylolisthesis; spinal stenosis; trauma (fracture/dislocation); failed previous fusion; tumors. The Spinal Elements Lotus Posterior Cervical/Thoracic Spinal System may be used in conjunction with the Spinal Elements Mercury system for transition at T1 - T3.

    The use of polyaxial pedicle screws is limited to placement in TI-T3 for treating thoracic conditions only. The screws are not intended to be placed in the cervical spine.

    Device Description

    The Spinal Elements Lotus Posterior Cervical/Thoracic System consists of a variety of fixation devices that are attached to the spine by means of screws and hooks placed in/or on the pedicles or posterior elements of the various vertebrae, rods that span the distance between the screws/hooks. Screws are intended for attachment to the thoracic (T1-T3) spine only. The system achieves fixation by the mechanical joining of the rods, screws, and hooks. A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient.

    Connectors are offered in a variety of sizes and configurations and are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F 1472 and / or F 136. The following connectors are being added to the system:

    • Offset connector .
    • Round offset connector .
    • Axial rod to rod connector .
    • 03.5mm Axial rod to rod connector o
    • 0 5.5mm Axial rod to rod connector .
    • Parallel rod to rod connector .
    • . 0 3.5mm Parallel rod to rod connector
    • 0 5.5mm Parallel rod to rod connector ●
    • Transition rods .
    AI/ML Overview

    The provided text describes a medical device, the Spinal Elements Lotus® Posterior Cervical/Thoracic Spinal System, and its clearance through a 510(k) premarket notification. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. Instead, the document outlines the device's description, intended use, and the performance testing conducted to demonstrate substantial equivalence to a previously cleared device.

    Therefore, I cannot fulfill the request as it asks for information not present in the provided text regarding acceptance criteria, device performance, AI/ML study details, and data provenance. The document is a 510(k) summary for a traditional medical device (spinal fixation system), not an AI/ML powered device.

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