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    K Number
    K240393
    Device Name
    Exactech® TRULIANT® Knee System
    Manufacturer
    Exactech Inc.
    Date Cleared
    2024-10-03

    (238 days)

    Product Code
    MBH,JWH
    Regulation Number
    888.3565
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K182346
    Why did this record match?
    Device Name :

    Exactech**®** TRULIANT**®** Knee System

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

    The Exactech® TRULIANT® Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

    The TRULIANT Cemented Femoral Components, Tibial Inserts, and Tibial Trays are indicated for cemented use only. The TRULIANT Porous Femoral Components are indicated for cemented or cementless use. The TRULIANT Porous Tibial Trays are indicated for cemented or cementless use.

    Device Description

    The Exactech® Truliant® Knee System is a total knee replacement system comprised of femoral, tibial, and patellar implants. The proposed Porous Tibias are additional tibial tray implant variants intended for use with the Truliant Knee System. This submission proposes Truliant Porous Tibial Trays made from titanium alloy consolidated via direct metal laser sintering (DMLS). This submission additionally proposes a Porous Tibial Tray variant without screw holes, additional intermediate tray sizes, and minor geometric change(s) to the predicate Porous Tibial Tray design.

    AI/ML Overview

    This document is a 510(k) Premarket Notification from the FDA regarding the Exactech® TRULIANT® Knee System. It does not describe an AI/ML device and therefore does not contain the specific information requested in the prompt about acceptance criteria for an AI model, such as performance metrics like sensitivity/specificity, AI model training/test sets, expert adjudication, or MRMC studies.

    The document discusses the substantial equivalence of a medical device (a knee replacement system) to a legally marketed predicate device. The performance data presented relates to engineering and biocompatibility testing for a physical implant, not an AI algorithm.

    Therefore, I cannot extract the requested information as it is not present in the provided text.

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