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510(k) Data Aggregation

    K Number
    K193203

    Validate with FDA (Live)

    Device Name
    MOJAVE Expandable Interbody System
    Manufacturer
    K2M, Inc.
    Date Cleared
    2020-02-18

    (90 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K171097,K163364
    Predicate For
    K211474,K211873,K221490
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MOJAVE Expandable Interbody System implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DOD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy. Additionally, the MOJAVE lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. MOJAVE lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

    Device Description

    The MOJAVE Expandable Interbody System is comprised of expandable titanium implants designed to allow for intraoperative adjustment to aid the surgeon in matching implant fit to the vertebral anatomy in the lumbar spine. The implants have titanium endplates designed to allow for bone ingrowth and engagement with the vertebral body end plates. The implants are manufactured from medical grade titanium alloy (ASTM F1472, ASTM F136, ASTM F3001) and cobalt chromium alloy (ASTM F1537) and are available in a variety of heights to accommodate anatomical variations.

    AI/ML Overview

    The provided document describes an FDA 510(k) clearance for the MOJAVE Expandable Interbody System. This is a medical device, not an AI/software product, and the information provided does not include acceptance criteria or a study proving that an AI/software device meets acceptance criteria.

    The document discusses the substantial equivalence of the MOJAVE Expandable Interbody System to predicate devices based on:

    • Technological Comparison to Predicate: Minor modifications to enhance user experience, comparable in design, function, intended use, materials, and size.
    • Non-clinical Performance Evaluation: Risk assessment, including benchtop and mechanical testing, to confirm no new issues of safety or effectiveness.

    Therefore, I cannot provide the requested information for an AI/software device from this text as it is not applicable.

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