LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K031318
    Device Name
    TRAXIS CEMENT RESTRICTOR
    Manufacturer
    SPINAL CONCEPTS, INC.
    Date Cleared
    2003-08-22

    (119 days)

    Product Code
    JDK
    Regulation Number
    878.3300
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K022218,K023647
    Why did this record match?
    Device Name :

    TRAXIS CEMENT RESTRICTOR

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

    The TraXis Cement Restrictor System is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

    This device is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.

    Device Description

    The Spinal Concepts Inc. TraXis Cement Restrictor is a modified version of the Spinal Concepts Cadence Cement Restrictor (K022218 and K023647). Both are indicated for use as cement restrictors in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.

    TraXis is crafted from titanium alloy (ASTM F136) or PEEK OPTIMA™ (polyaryletheretherketone, ASTM F2026). As PEEK OPTIMA™ is radiolucent, radiographic markers are included in the distal and proximal ends of the PEEK implants. The markers consist of tantalum wires (ASTM F560) that are press-fit into small holes in the implant.

    TraXis is offered in various lengths, widths and heights. TraXis is intended for restriction of bone cement in the distal femoral canal.

    AI/ML Overview

    The provided text for K031318, "Spinal Concepts, Inc. TraXis™ Cement Restrictor," does not include information about acceptance criteria or a study proving the device meets said criteria.

    The document is a 510(k) summary for a medical device and primarily focuses on:

    • Device description and its components.
    • Indications for use.
    • Identification of a predicate device (Spinal Concepts Inc. Cadence™ Cement Restrictor).
    • A statement regarding mechanical tests: "No mechanical tests were performed to support this application."
    • The FDA's decision regarding substantial equivalence and required labeling limitations.

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance tables, study details, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies based on the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1