BEUDAMED
    FDA PMA FDA Class 3 Approved (Reclassification) 🇺🇸 United States

    Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

    PMA: P940002 · Decision Mar 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
    Trade Name
    NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM)
    PMA Number
    P940002
    Device Class
    FDA Class 3
    Product Code
    MBD
    Generic Name
    PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    March 21, 1997
    Date Received
    January 14, 1994
    Expedited Review
    N
    Docket Number
    97M-0252

    Advisory Committee Statement

    APPROVAL FOR THE NATURAL-KNEE(R) AND NATURAL KNEE(R) II WITH CSTI(TM). THESE DEVICES ARE INDICATED FOR UNCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS WITH INTACT MEDIAL AND LATERAL COLLATERAL LIGAMENTS UNDERGOING PRIMARY SURGERY FOR REHABILITATING KNEES DAMAGED AS A RESULT FO NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR INFLAMMATORY JOINT DISEASE (IJD)

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MBD Prosthesis, Knee, Patello/Femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer