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510(k) Data Aggregation

    K Number
    K243991
    Device Name
    Klassic Knee System - Revision Tibial Baseplate
    Manufacturer
    Total Joint Othopedics, Inc.
    Date Cleared
    2025-03-24

    (88 days)

    Product Code
    JWH,MBH,OIY
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K112906,K230537
    Why did this record match?
    Device Name :

    Klassic Knee System - Revision Tibial Baseplate

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

    The Klassic® Knee System is intended for prosthetic replacement of the following:

    • · Patient conditions of non-inflammatory degenerative joint disease (NID); avascular necrosis and osteoarthritis
    • · Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
    • · Patients with failed previous surgery where pain, deformity, or dysfunction persists
    • · Correctable varus-valgus deformity and moderate flexion contracture
    • · Revision of a previously failed knee arthroplasty
    • · Patients who require a total knee replacement

    The Klassic® Knee System is indicated for cemented use only, except for the Klassic Femur, with Cobalt 3D®, the Klassic Tibial Baseplate with Ti-Coat®, and the Universal™ Cones with Ti-Coat® which are also indicated for cementless use.

    Device Description

    The Klassic® Tibial Baseplate, Revision (Ti6Al4V) is being introduced as a line extension for use with the Klassic® Knee System during total knee arthroplasty.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (Klassic Knee System - Revision Tibial Baseplate) and a summary of the device, its indications for use, and a discussion of non-clinical testing.

    However, it does not include any details on:

    1. Acceptance criteria and reported device performance in a table format.
    2. Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for any clinical or performance studies.
    3. Training set sample size or ground truth establishment for a machine learning model.

    The document discusses non-clinical testing (e.g., fatigue analysis, modular interface fatigue testing, fretting corrosion analysis, MRI safety testing) and states that "Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Design Control Activities." However, it does not specify what those acceptance criteria were or the precise performance metrics and their achieved values.

    Therefore, I cannot fulfill your request based on the provided text.

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