BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Intervertebral Disc

    PMA: P120024 · Decision Jun 11, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73

    Basic Information

    Device Name
    Prosthesis, Intervertebral Disc
    Trade Name
    ACTIVL ARTIFICIAL DISC
    PMA Number
    P120024
    Device Class
    FDA Class 3
    Product Code
    MJO
    Generic Name
    Prosthesis, intervertebral disc
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 11, 2015
    Date Received
    December 18, 2012
    Expedited Review
    N
    Docket Number
    15M-2218

    Advisory Committee Statement

    APPROVAL FOR THE ACTIVL® ARTIFICIAL DISC. THIS DEVICE IS INDICATED FOR RECONSTRUCTION OF THE DISC AT ONE LEVEL (L4-L5 OR L5-S1) FOLLOWING SINGLE-LEVEL DISCECTOMY IN SKELETALLY MATURE PATIENTS WITH SYMPTOMATIC DEGENERATIVE DISC DISEASE (DDD) WITH NO MORE THAN GRADE I SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY, PHYSICAL EXAMINATION, AND RADIOGRAPHIC STUDIES. THE ACTIVL® ARTIFICIAL DISC IS IMPLANTED USING AN ANTERIOR RETROPERITONEAL APPROACH. PATIENTS RECEIVING THE ACTIVL® ARTIFICIAL DISC SHOULD HAVE FAILED AT LEAST SIX MONTHS OF NONOPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE DEVICE.

    Classifications

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

    Product Code Device Name
    MJO Prosthesis, Intervertebral Disc