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510(k) Data Aggregation

    K Number
    K131679
    Date Cleared
    2013-10-23

    (135 days)

    Product Code
    Regulation Number
    888.3560
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    EVOLUTION MP ADAPTIVE PS TIBIAL INSERT

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

    The EVOLUTION® MP Adaptive PS Insert is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

    1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
    2. Inflammatory degenerative joint disease including rheumatoid arthritis;
    3. Correction of functional deformity;
    4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
      The EVOLUTION® Total Knee System is for cemented use only.
    Device Description

    The purpose of this submission is to introduce a new EVOLUTION® MP Adaptive PS Tibial Insert that allows use of a posterior stabilized femoral component from the EVOLUTION® MP Total Knee System with a tibial base from the ADVANCE® Knee System.
    The design features of the EVOLUTION® Adaptive CS Insert are summarized below:

    • Tibial inserts manufactured from UHMWPE
    • Available in 7 sizes, left and right
    • Tibial insert thickness: 10 20mm
    AI/ML Overview

    This document does not describe an AI/ML medical device. It pertains to a physical medical device, specifically a tibial insert for knee arthroplasty. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement for an AI/ML device is not applicable and cannot be extracted from this text.

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