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510(k) Data Aggregation

    K Number
    K181350
    Device Name
    ASTRA-OCT Spine System
    Manufacturer
    SpineCraft LLC
    Date Cleared
    2018-07-06

    (45 days)

    Product Code
    NKG,KWP
    Regulation Number
    888.3075
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K954696,K143683,K080828,K110353,K151885,K090714,K091365,K093434,K110522,K123656,K143471,K090549,K133698,K141897,K142838,K013222,K022190,K030103,K041203,K150552,K132122
    Why did this record match?
    Device Name :

    ASTRA-OCT Spine System

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

    The ASTRA-OCT Spine System implants are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3):

    • · Traumatic spinal fractures and/or Traumatic dislocations;
    • Instability or deformity;
    • · Failed previous fusions (e.g. pseudoarthrosis);
    • · Tumors involving the cervical/thoracic spine: and
      · Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

    The ASTRA-OCT Spine System implants are also 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 order to achieve additional levels of fixation, the ASTRA-OCT Spine System rods may be connected to other occipital cervical thoracic or thoracolumbar stabilization rod systems ranging in diameter from 3.5mm, including the ASTRA or APEX Spine Systems, using corresponding connectors.

    Device Description

    The ASTRA-OCT Spine System consists of a series of polyaxial screws, occipital screws, occipital plates, hooks, rods, lateral connectors, rod-to-rod connectors, set screws, and cross connectors.

    Materials:
    Titanium alloy per ASTM F136 CoCr allov per ASTM F1537

    AI/ML Overview

    This FDA 510(k) summary describes a new medical device, the ASTRA-OCT Spine System, and its substantial equivalence to a predicate device. The information provided is for a traditional medical device (spinal implant) and does not include acceptance criteria or a study proving device meets acceptance criteria in the context of an AI/ML powered device.

    Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device.

    The document states:

    • "No clinical studies were performed" for the ASTRA-OCT Spine System.
    • The substantiation for equivalence is based on non-clinical mechanical testing and comparison to predicate systems.

    The requested information is typically found in submissions for AI/ML powered devices, which are assessed differently from traditional hardware devices like the ASTRA-OCT Spine System.

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