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510(k) Data Aggregation

    K Number
    K182251
    Device Name
    EVOLUTION NitrX Medial-Pivot Knee
    Manufacturer
    MircoPort Orthopedics, Inc.
    Date Cleared
    2019-05-16

    (269 days)

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

    MircoPort Orthopedics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EVOLUTION® NitrX™ Medial-Pivot Knee is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; 3. Correction of functional deformity 4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.
    Device Description
    The EVOLUTION® NitrX™ Medial-Pivot Knee is a line extension of the EVOLUTION® MP Total Knee System product line. The device is intended to be used as a medial pivot option in total knee arthroplasty (TKA). The subject device is composed of a femoral component to replace the distal surface of the patient's natural femur and a tibial baseplate component to replace the proximal surface of the patient's natural tibia. The design features are summarized below: - Manufactured from Cobalt Chrome Alloy - Coated with Titanium Niobium Nitride - Sizes 1-8, left and right
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