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510(k) Data Aggregation

    K Number
    K033303
    Device Name
    WAFER SYSTEM
    Manufacturer
    SPINE WAVE, INC.
    Date Cleared
    2004-06-24

    (254 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K973812,K011583
    Why did this record match?
    Device Name :

    WAFER SYSTEM

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

    The Wafer System, in conjunction with commercially available supplemental fixation, is intended for use in proximal tibial opening wedge osteotomies as a means to restore anatomical alignment and relative position.

    Device Description

    The Wafer System consists of a delivery gun, a delivery track and a wafer cartridge assembly. The Wafers are used to open the osteotomy and act as a spacer until bone graft and supplemental fixation can be placed. The Wafer System Implants are manufactured from Polyetheretherketone (PEEK) with 6% Barium Sulfate.

    AI/ML Overview

    The provided text describes the "Wafer System," an orthopedic device, and details its 510(k) submission. However, it does not contain information about acceptance criteria, device performance studies to meet those criteria, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance) as requested.

    The document primarily focuses on:

    • Submitter and Device Information: Company name, contact, product name, common name, classification.
    • Device Description: Components (delivery gun, delivery track, wafer cartridge assembly, PEEK wafers with Barium Sulfate).
    • Intended Use: Proximal tibial opening wedge osteotomies, in conjunction with supplemental fixation, to restore anatomical alignment and relative position.
    • Substantial Equivalence: To Arthrex Opening Wedge Osteotomy System (K973812) and Synthes Spiked Washer (K011583).
    • Mechanical Testing: A brief mention that "mechanical testing demonstrated that The Wafer System met the performance requirements for its intended use." No details of these tests, specific criteria, or results are provided.
    • FDA Approval Letter: A standard FDA 510(k) clearance letter.

    Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance study details from the provided text. The document only confirms the device's clearance based on substantial equivalence and a general statement about mechanical testing.

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