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510(k) Data Aggregation

    K Number
    K131296

    Validate with FDA (Live)

    Device Name
    VARILIFT-L INTERBODY FUSION DEVICE
    Manufacturer
    WENZEL SPINE, INC.
    Date Cleared
    2013-09-03

    (120 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K100820,K111525,K090353
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Wenzel Spine VariLift Interbody Fusion System (VariLift-L and VariLift-A) is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of decenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

    VariLift-L is designed to be implanted bi-laterally via a posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-A is designed to be implanted bl-laterally via an anterior (ALIF) approach. VariLift-L and VariLift-A may be implanted with or without supplemental fixation and are intended for use with autograft to facilitate fusion.

    Device Description

    The Wenzel Spine VariLift Interbody Fusion System is offered in two (2) configurations of various sizes that are designed based on surgical approach, and consist of:

      1. VariLift-L®, which may be implanted bi-laterally via a posterior lumbar (PLIF) approach or as a single device via a transverse (TLIF) approach.
      1. VariLift-A®, which may be implanted bi-laterally via an anterior (ALIF) approach.

    A design change was made on all sizes of the VariLift-L® devices to eliminate the risk of orientation error when loading the implant on the insertion instruments. Additionally, dimensional and threadform modifications were made to the instrumentation to ensure all instruments work with the modified devices.

    The VariLift-L® and VariLift-A® are self-tapping, expandable devices with an interior sliding wedge and a posterior end cap. They are grooved and fluted devices with large fenestrations (graft windows) positioned between each of the four quadrants that provide bony contact with the endplates. The devices are made of titanium alloy (per ASTM F136).

    AI/ML Overview

    The provided text discusses the substantial equivalence of the Wenzel Spine VariLift-L Interbody Fusion Device to a predicate device based on non-clinical performance testing. It does not describe acceptance criteria, a study proving device meets acceptance criteria, or any information related to AI/algorithm performance.

    Therefore, I cannot provide the requested information. The text focuses on the mechanical performance of the VariLift-L device and modifications, concluding that it is substantially equivalent to a previously cleared device. There is no mention of an algorithm, AI, human readers, ground truth, or any of the other specific study parameters you asked about.

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