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    K Number
    K251479
    Device Name
    Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))
    Manufacturer
    Mobarn Medical Devices, LLC.
    Date Cleared
    2025-09-18

    (128 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K143258,K171495
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Mobarn 80:20 Lumbar Interbody Fusion System is intended for spinal fusion procedures to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had previous non-fusion spinal surgery at the involved spinal level(s) and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Mobarn 80:20 Lumbar Interbody Fusion System is to be combined with supplemental fixation.

    Device Description

    The Mobarn 80:20 Lumbar Interbody Fusion System consists of a family of additively manufactured titanium (Ti6Al4V-ELI) lumbar intervertebral body fusion devices (LIBF) designed to facilitate lumbar spinal fusion through various surgical approaches, as listed below.

    • Posterior Lumbar Interbody Fusion (PLIF)
    • Transforaminal Lumbar Interbody Fusion (TLIF)
    • Direct Lateral Lumbar Interbody Fusion (DLIF)
    • Anterior Lumbar Interbody Fusion (ALIF)

    The Mobarn 80:20 Lumbar Interbody Fusion System is intended for use in lumbar intervertebral fusion procedures. These devices are designed to provide structural support and stabilization to facilitate bony fusion in patients with degenerative disc disease (DDD) and other conditions requiring interbody fusion.

    The design of the implants consists of an open architecture surrounded by a titanium frame to accommodate autograft and/or allogenic bone graft, comprised of cancellous and/or cortico-cancellous bone graft. Each implant is engineered with an 80% open area to accommodate autograft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft, maximizing bone graft contact and fusion potential, while maintaining mechanical integrity through a titanium frame that makes up the remaining 20% and offers structural support. The implants are available in a variety of footprints, heights, and lordotic angles to approximate anatomical variation in different vertebral levels and/or patient anatomy.

    AI/ML Overview

    N/A

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