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510(k) Data Aggregation

    K Number
    K964951
    Device Name
    KINEMAX PLUS TIBIAL SPACERS
    Manufacturer
    HOWMEDICA CORP.
    Date Cleared
    1997-02-24

    (76 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K915512,K884837,K872379,K915132,K922285,K896542,K901457,K903286,K914072
    Predicate For
    K983072
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Kinemax® Plus Tibial Spacers are intended to be used with the tibial baseplates of the Kinemax® Plus and Kinemax® Plus Superstabilizer total knee systems in primary or revision total knee replacement procedures where there is bone loss on the tibia that requires augmentation for stability. The spacers may be cemented to the baseplate, or may be mechanically locked into place with fixation screws or fixation pegs. The baseplate-spacer assembly is then cemented onto the prepared proximal tibia.

    Device Description

    There are three types of spacers in the Kinemax® Plus Tibial Spacer System: a half spacer, a full spacer, and a full angled spacer. These spacers are fabricated from cast Vitallium® allov. The fixation screws and pegs used to secure these spacers to the tibial baseplates are fabricated from wrought or cast Vitallium® alloy. These products will be sold sterile.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary for a medical device (Kinemax® Plus Tibial Spacers) and does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found for AI/software-based medical devices.

    The document describes:

    • Device identification: Kinemax® Plus Tibial Spacers
    • Intended use: Augmentation for tibias with bone loss in total knee replacement.
    • Device description: Three types of spacers, fabricated from cast Vitallium® alloy, with fixation screws/pegs. Sold sterile.
    • Substantial equivalence: Compares the device to other legally marketed products (listed with K numbers).
    • Contact information.

    There is no mention of:

    1. A table of acceptance criteria and reported performance.
    2. Sample size, data provenance, ground truth, or expert qualifications for a test set.
    3. Adjudication methods.
    4. MRMC studies or human reader improvement with AI.
    5. Standalone algorithm performance.
    6. Type of ground truth.
    7. Training set details.

    This type of 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting clinical or performance study data in the way you've outlined for AI/software devices.

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