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510(k) Data Aggregation

    K Number
    K991052
    Device Name
    FS 1000 KNEE SYSTEM
    Manufacturer
    RENAISSANCE INSTRUMENTS, LLC.
    Date Cleared
    1999-11-10

    (225 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    RENAISSANCE INSTRUMENTS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FS 1000 Knee System is intended for single-use cemented implantation for use in total knee arthroplasty surgery for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: - Non-inflammatory degenerative joint disease resulting from osteoarthritis, traumatic arthritis, or avascular necrosis; - Inflammatory degenerative joint disease including rheumatoid arthritis; - Correction of varus, valgus, or post traumatic deformity; - Correction or revision of unsuccessful osteotomy or arthrodesis; and - Revision procedures where other treatments or devices have failed; OR - Treatment of fractures that are unmanageable using other techniques;
    Device Description
    Not Found
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