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510(k) Data Aggregation

    K Number
    K060506
    Device Name
    STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
    Manufacturer
    STRYKER SPINE
    Date Cleared
    2006-05-25

    (87 days)

    Product Code
    MQP
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K050624,K003836,K003709,K003043
    Predicate For
    K091946,K112756,K221490
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Stryker Spine VLIFT™ is a vertebral body replacement system intended to replace a vertebral body or an entire vertebra. It is for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body or vertebra resected or excised during total and partial corpectomy and vertebrectomy procedures due to tumor or trauma (i.e., fracture). For both corpectomy and vertebrectomy procedures, the VLIFT™ system is intended to be used with supplemental internal fixation systems. The supplemental internal fixation systems that may be used with VLIFT™ include, but are not limited to Stryker Spine plate or rod systems (Xia Spinal System, Spiral Radius 90D, and Trio). The use of bone graft with VLIFT™ is optional.

    Device Description

    Stryker Spine VLIFT™ is a vertebral body replacement system, intended for use as an aid in spinal fusion.

    The VLIFT™ vertebral body replacement system consists of a single, pre-assembled cylindrically shaped titanium cage, with a distractible or retractable center. The hollow core of the cage allows for packing bone graft. The use of bone graft with VLIFT™ is optional.

    The VLIFT™ cages are available in two (2) diameters (18 mm and 22 mm) and cover a range of heights from 18.5 to 58.5 mm. The end caps are available in a variety of round angled shapes to better match the sagittal angle of the spinal segment.

    The optional extension pieces are offered for both the 18mm and 22mm diameter cages. Each extension piece adds 15mm to the construct height. One or two extensions can be assembled to the implant, which creates a maximum construct height of 88.5 mm.

    AI/ML Overview

    I'm sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is primarily a 510(k) summary for the Stryker Spine VLIFT™ Vertebral Body Replacement System, detailing its description, intended use, and substantial equivalence to predicate devices. It mentions "Testing to demonstrate compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was completed," but it does not describe the specific tests, acceptance criteria, or performance results from such a study.

    Therefore, I cannot provide the requested information in the table format or answer the specific questions about sample size, data provenance, ground truth, expert involvement, or MRMC studies.

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