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510(k) Data Aggregation

    K Number
    K181262
    Device Name
    SpineJack Expansion Kit
    Manufacturer
    Vexim SA
    Date Cleared
    2018-08-30

    (111 days)

    Product Code
    NDN
    Regulation Number
    888.3027
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K053336,K041454,K132817
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vexim SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spinelack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. It is intended to be used in combination with Stryker Vertaplex HV bone cements.

    Device Description

    The SpineJack Expansion Kit (herein referred to as "SpineJack") is an implanted fracture reduction system, intended to reduce vertebral compression fractures. The SpineJack Expansion Kit is used with the Preparation Kit. The Expansion Kit is available in three sizes, to accommodate different vertebral body sizes, Ø4.2mm, Ø5mm, and Ø5.8mm. After the SpineJack implant is inserted, it is expanded, and PMMA bone cement is injected at a low pressure to stabilize the restored vertebral body. The bone cement and its delivery system are intended to be used with the SpineJack, but are sold separately.

    AI/ML Overview

    This document describes the premarket notification (510(k)) clearance for the SpineJack® Expansion Kit, a medical device used to treat painful osteoporotic vertebral compression fractures. The document outlines the device's indications for use, comparison to predicate devices, and the results of performance and clinical testing to demonstrate substantial equivalence.

    Here's a breakdown of the requested information based on the provided text, focusing on the clinical study (SAKOS study) as the primary proof of meeting acceptance criteria:

    1. A table of acceptance criteria and the reported device performance

    The primary acceptance criteria for the SpineJack device were demonstrated through a non-inferiority study compared to Balloon Kyphoplasty (BKP). The key criteria and results were:

    Acceptance Criteria (Endpoint)Reported Device Performance (SpineJack vs. BKP)
    Primary Endpoint: 12-month Responder Rate (Non-Inferiority)
    Defined as clinically meaningful improvement in pain and function without pre-specified serious adverse events or reinterventions.SpineJack: 89.8% responder rate
    BKP: 87.3% responder rate
    Result: p=0.0016. The posterior probability for the final Bayesian analysis (0.09969) successfully met the criteria for study success (posterior probability > 0.987) and demonstrated non-inferiority of the SpineJack to the predicate BKP.
    Secondary Endpoint: Additional Composite Endpoint (Superiority)
    Defined as the primary endpoint components plus "absence of adjacent level fractures."SpineJack: 79.7% responder rate
    BKP: 59.3% responder rate
    Result: p
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