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510(k) Data Aggregation

    K Number
    K253377
    Device Name
    Expandable Titanium PLIF/TLIF System
    Manufacturer
    Spectrum Spine, Inc.
    Date Cleared
    2025-10-24

    (24 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K201024,K240838,K243074,K193256
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spectrum Spine Expandable Titanium PLIF/TLIF System includes interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

    Spectrum Spine Expandable Titanium PLIF/TLIF System implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

    Device Description

    The Spectrum Spine Expandable Titanium PLIF/TLIF System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The Expandable Titanium PLIF/TLIF System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to a set height and lordosis as appropriate. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Expandable Titanium PLIF/TLIF System is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

    The Expandable Titanium PLIF/TLIF System is manufactured from titanium alloy per ASTM F136.

    The system provides several footprints in multiple height and angle configurations. The cage's ability to be inserted at a nominal height and then expand to a set height and angle to fill the joint space once properly positioned minimizes damage to the bony end-plate caused by impaction.

    The purpose of this special 510(k) is to gain clearance for modifications made to the Expandable Titanium PLIF/TLIF System.

    AI/ML Overview

    N/A

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