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510(k) Data Aggregation

    K Number
    K161363
    Device Name
    Arsenal Spinal Fixation System
    Manufacturer
    ALPHATEC SPINE, INC
    Date Cleared
    2016-06-10

    (24 days)

    Product Code
    NKB,KWP,MNH,MNI,OSH
    Regulation Number
    888.3070
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K100685,K142591,K133221,K143149,K152968
    Why did this record match?
    Reference Devices :

    K100685, K142591

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

    The Arsenal Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis); tumor; pseudarthrosis; and/or failed previous fusion.

    When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Arsenal Spinal Fixation System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, lyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Arsenal Spinal Fixation System is intended to treat pediatic patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. Pediativ pedicle screw fixation is limited to a posterior approach.

    The Arsenal Spinal Fixation System is intended to be used with autograft and/or allograft.

    Device Description

    The Arsenal Spinal Fixation System is a posterior, non-cervical, spinal fixation system consisting of a variety of shapes and sizes of rods, screws, bridges and connectors to provide temporary internal fixation and stabilization during bone graft healing as an adjunct to fusion of the thoracic, lumbar and sacral spine.

    The purpose of this Special 510(k) Premarket Notification is to add cannulated implants and MIS rods to the currently marketed Arsenal Spinal Fixation System.

    AI/ML Overview

    The provided text is a 510(k) Premarket Notification for the Arsenal™ Spinal Fixation System. This document is a regulatory submission for a medical device and, as such, does not contain information on acceptance criteria for an AI/algorithm-driven device or a study proving that an AI device meets acceptance criteria.

    The document discusses a spinal fixation system, which is a physical implant, not a software or AI-based device. The "Performance Data" section refers to mechanical testing (e.g., ASTM F 1717, ASTM F1798) to demonstrate the physical device's equivalence to predicate devices, not performance metrics of an AI.

    Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI device from this document.

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