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510(k) Data Aggregation

    K Number
    K020214
    Device Name
    MEDIAL ROTATION KNEE SYSTEM
    Manufacturer
    ENGINEERING CONSULTING SERVICES, INC.
    Date Cleared
    2002-02-26

    (35 days)

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

    ENGINEERING CONSULTING SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medial Rotation Knee™ System is intended for single-use cemented implantation for use in total knee arthroplasty surgery for the reduction in 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 • Revision procedures where other treatments or devices have failed • Treatment of fractures that are unmanageable using other techniques
    Device Description
    The Medial Rotation Knee™ System is both a primary and revision total knee system composed of a CoCr Femoral component mating with a stemmed CoCr metal backed polyethylene Tibial and all-poly Patella components. The conguency in tibialfemoral and patellafemoral articulation allow for natural knee movement and ROM while minimizing polyethelene wear.
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