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510(k) Data Aggregation

    K Number
    K180159
    Device Name
    Klassic® Knee System
    Manufacturer
    Total Joint Orthopedics, Inc.
    Date Cleared
    2018-03-09

    (49 days)

    Product Code
    JWH,MBH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K141972,K112802,K112906,K140942,K150105,K153075,K153310,K162422
    Why did this record match?
    Device Name :

    Klassic**®** Knee System

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

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

    • Patient conditions of non-inflammatory degenerative joint disease (NIDJ): . 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, Porous, and the Klassic Tibial Baseplate, Porous, which are indicated for cementless use.

    Device Description

    The purpose of this 510(k) is to add Klassic® Knee CR/Congruent Tibial Inserts with E-Link®, Ultra-PS® Tibial Inserts with E-Link®, Sombrero Patellae with E-Link® and Domed Patellae with E-Link® ("E-Link® Knee Components") to the Klassic® Knee System. These components are manufactured from E-link®, a Vitamin E blended UHMWPE crosslinked by gamma irradiation. The E-Link® Knee Components are available in various sizes and thicknesses to match patient anatomy.

    AI/ML Overview

    The provided text is a 510(k) summary for the Klassic® Knee System. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML-enabled device. The document is for a traditional medical device (knee replacement system) and focuses on substantial equivalence based on engineering analyses and bench testing, rather than performance metrics related to diagnostic or predictive accuracy.

    Therefore, I cannot provide the requested information. The document does not describe any AI/ML model.

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