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510(k) Data Aggregation

    K Number
    K252327

    Validate with FDA (Live)

    Device Name
    CMORE® CT System; CMORE® CT System Navigated Instruments
    Manufacturer
    icotec ag
    Date Cleared
    2025-11-12

    (110 days)

    Product Code
    NKG
    Regulation Number
    888.3075
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K181949,K242516,K233989,K231850
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CMORE® CT System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

    In patients requiring adjuvant radiotherapy following spinal stabilization, metal markers at the screw tips can be used as fiducial markers in radiotherapy treatments (e.g., SBRT, proton therapy).

    The CMORE® CT System is intended to provide immobilization and stabilization of spinal segments with anterior interbody support implanted at the same spinal level/s as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the upper thoracic spine (T1 to T3):

    • Traumatic spinal fractures and/or traumatic dislocations
    • Instability or deformity
    • Failed previous fusions (e.g. pseudarthrosis)
    • Degenerative disease, including intractable radiculopathy and/or myelopathy
    • Neck and/or arm pain of discogenic origin as confirmed by radiographic studies
    • Degenerative disease of the facets with instability
    • Patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

    The CMORE® CT System is intended to be used with anterior interbody support implanted at the same spinal level/s with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

    The CMORE® CT System may be connected to the VADER® Pedicle System using connectors.

    CMORE® CT System Navigated Instruments
    CMORE® CT System Navigated Instruments are intended to be used during the preparation and placement of the CMORE® CT System during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. These instruments are designed for use with the Medtronic StealthStation® and Brainlab Navigation Systems which are indicated for any medical condition in which the use of stereotactic surgery may by appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT- or MR- based model, fluoroscopy images, or digitized landmarks of anatomy.

    Device Description

    CMORE® CT System
    The CMORE® CT System is a posterior cervical fixation system intended to provide structural stability and mechanical support to the cervical and upper thoracic spine. The CMORE® CT System is manufactured from Carbon/PEEK using a proprietary manufacturing process and is comprised of screws, rods, nut screws, and connectors as well as corresponding instruments.

    CMORE® CT System System Navigated Instruments
    The CMORE® CT System Navigated Instruments are reusable instruments used for the preparation and placement of FDA-cleared spinal bone screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. These instruments are designed to be used with the Medtronic StealthStation® and Brainlab Navigation Systems. The instruments include awls, drills, probes, taps, drivers, and adapters.

    AI/ML Overview

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