BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

    PMA: P000057 · Decision Nov 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
    Trade Name
    ASCENSION MCP
    PMA Number
    P000057
    Device Class
    FDA Class 3
    Product Code
    NEG
    Generic Name
    Finger semi-constrained pyrolytic carbon uncemented prosthesis
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 19, 2001
    Date Received
    December 29, 2000
    Expedited Review
    Y
    Docket Number
    01M-0530

    Advisory Committee Statement

    THIS DEVICE IS INDICATED FOR USE AS A TOTAL JOINT REPLACEMENT OF INDEX, LONG, RING, AND SMALL FINGER METACARPOPHALANGEAL JOINTS THAT EXHIBIT SYMPTOMS OF PAIN, LIMITED MOTION, OR INADEQUATE BONY ALIGNMENT (I.E., SUBLUXATION/DISLOCATION) SECONDRY TO ARTICULAR DESTRUCTION OR DEGENERATIVE DISEASE RELATED TO RHEUMATOID ARTHRITIS, LUPUS ERYTHEMATOSUS, OSTEOARTHRITIS, OR POST TRAUMATIC ARTHRITIS WHERE SOFT TISSUE RECONSTRUCTION CAN PROVIDE ADEQUATE STABILIZATION.

    Classifications

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

    Product Code Device Name
    NEG Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis