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510(k) Data Aggregation

    K Number
    K122883
    Device Name
    EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2013-08-05

    (319 days)

    Product Code
    JWH,OIY
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K980276,K063211,K094035,K113550
    Why did this record match?
    Device Name :

    EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM

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

    The Proven Gen-Flex™ Total Knee System is intended for:

    • Total knee replacement due to osteoarthritis. osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems.
    • Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
      The device is intended for cemented use only.
    Device Description

    The EXp Tibial Inserts and Patellar Components are made of polyethylene to which Vitamin E has been blended. The tibial inserts are available in "Cruciate Retaining" (CR) and "Posterior Stabilized" (PS) designs. The patellar components are available Single Peg and Three Peg designs. These implants are part of the Proven Gen-Flex™ Total Knee System and will be used in conjunction with a femoral component and tibial baseplate in total knee arthroplasty.

    AI/ML Overview

    This document describes the 510(k) summary for the EXp Tibial Inserts and Patellar Components for StelKast's Proven Gen-Flex™ Total Knee System, a medical device. This information is not a diagnostic AI device, so the requested information about acceptance criteria, study details, and expert involvement is not applicable.

    The document indicates "Preclinical Testing" was performed, which included:

    • Non-clinical testing: Assessed the interconnection mechanism between the insert and tibial baseplate, and the integrity of the tibial post on the posterior-stabilized design.
    • Knee simulator wear testing: Per ISO 14243-1.
    • Oxidative stability testing: Per ASTM F2102, after aging per ASTM F2003, after 10 million cycles of knee simulator wear testing.

    The document concludes that "The testing demonstrates that the EXp Tibial Inserts are substantially equivalent to legally marketed predicate devices." This is a regulatory statement of substantial equivalence, not a performance study against specific acceptance criteria for a diagnostic AI device.

    Therefore, I cannot provide the requested table and details because they are not present in the provided text, as the device is a knee implant, not a diagnostic AI system.

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