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510(k) Data Aggregation

    K Number
    K971020
    Device Name
    LSF TRIAD TOTAL HIP SYSTEM
    Manufacturer
    OSTEOIMPLANT TECHNOLOGY, INC.
    Date Cleared
    1997-06-18

    (90 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LSF TRIAD TOTAL HIP SYSTEM is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the "LSF® Triad Total Hip System." It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

    The letter purely states that the FDA has found the device to be "substantially equivalent" to devices marketed prior to May 28, 1976, meaning it can proceed to market. This type of regulatory approval does not typically involve detailed performance studies with acceptance criteria as described in the prompt.

    Therefore, I cannot extract the requested information from the provided text.

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