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    K Number
    K172334
    Device Name
    Ortus™ Expandable Lumbar Interbody Fusion System
    Manufacturer
    Atlas Spine, Inc.
    Date Cleared
    2017-10-25

    (84 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Ortus™ Expandable Lumbar Interbody Fusion System

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

    The Ortus™ Expandable Lumbar Interbody Fusion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s).

    The Ortus™ Expandable Lumbar Interbody Fusion System is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft; and supplemental fixation system (i.e. Apelo Pedicle Screw System).

    Patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with the Ortus™ Expandable Lumbar Interbody Fusion System.

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document contains no information about the acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for the "Ortus™ Expandable Lumbar Interbody Fusion System," detailing its indications for use and regulatory compliance. It does not include performance data, study designs, or acceptance criteria.

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