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510(k) Data Aggregation

    K Number
    K042973
    Device Name
    SOLITUDE UNIPOLAR HEAD
    Manufacturer
    ORTHO DEVELOPMENT CORP.
    Date Cleared
    2005-01-27

    (91 days)

    Product Code
    KWL
    Regulation Number
    888.3360
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Solitude™ Unipolar femoral head is intended for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include:

    1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis or post traumatic arthritis.
    2. Proximal femoral neck fractures or dislocation.
    3. Idiopathic avascular necrosis of the femoral head.
    4. Non-union of proximal femoral neck fractures.
    5. Treatment of fractures that are unmanageable using other forms of therapy.
    Device Description

    Solitude™ Unipolar Head

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for a medical device called Solitude™ Unipolar Head. It is not a study document and therefore does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, or study methodologies.

    The letter confirms that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

    Therefore, I cannot provide the requested information based on this input document.

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