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510(k) Data Aggregation

    K Number
    K051454
    Device Name
    ALEUTIAN SPACER SYSTEM
    Manufacturer
    K2M, LLC
    Date Cleared
    2005-07-27

    (55 days)

    Product Code
    MQP
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K043405,K042930,K043316,K003709
    Predicate For
    K063399,K063637,K081383,K082698,K092211,K110843,K111294,K111439,K120031,K140142
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Aleutian Spacer System is indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian Spacer System is designed to restore the integrity of the spinal column even in the absence of fusion for a prolonged period.

    The Aleutian Spacer System is intended to be used with supplemental internal fixation. The supplemental internal fixation intended to be used with this implant is the K2M Denali Spinal System.

    Device Description

    The Aleutian Spacer System consists of a hollow tube structure manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are available in a variety of different sizes and heights to match more closely the patient anatomy and which are designed to engage with the vertebral body end plates.

    Materials: The devices are manufactured from Medical Grade PEEK (Polyetherether): OPTIMA I T1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads to be Grade UNS R05200 according to ASTM F560.

    Function: The system functions as a vertebral body replacement device to assist in fusion and to provide stabilization of the thoraco-lumbar segments of the spine.

    AI/ML Overview

    The provided text is a 510(k) summary for the Aleutian Spacer System, a vertebral body replacement device. It establishes substantial equivalence by comparing it to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    Such information would typically be found in a performance study or clinical data section, which is absent from this summary. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials with predefined acceptance criteria.

    Therefore, I cannot provide the requested information based on the input text.

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