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510(k) Data Aggregation

    K Number
    K142253
    Device Name
    SOLSTICE OCT System
    Manufacturer
    LIFE SPINE, INC
    Date Cleared
    2015-04-23

    (252 days)

    Product Code
    KWP
    Regulation Number
    888.3050
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K090343,K083863
    Why did this record match?
    Reference Devices :

    K090343, K083863

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spinal stenosis; fracture/dislocation: Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.

    When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.

    The use of thoracic screws is limited to placement in T1-T3 for anchoring the construct only. They are not intended to be placed in the cervical spine.

    The hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

    Device Description

    The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, locking caps and breakaways.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device called the SOLSTICE OCT System. It is an FDA submission for substantial equivalence to legally marketed predicate devices, not a study describing acceptance criteria and device performance in the context of an AI/software as a medical device.

    Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information is not available within this document. The document focuses on regulatory compliance for a physical spinal implant system.

    The "Performance Data" section mentions "Mechanical Testing consisting of static and dynamic compression and torsion in accordance with ASTM 2706 as well interconnection testing was presented to show the substantial equivalence of the SOLSTICE OCT System." This refers to physical engineering tests, not clinical or algorithmic performance.

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