BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P850022 · Supplement: S016 · Decision Jul 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    ORTHOPAK 2 BONE GROWTH STIMULATOR SYSTEM
    PMA Number
    P850022
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    LOF
    Generic Name
    Stimulator, bone growth, non-invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 27, 2006
    Date Received
    February 6, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING DEVICE MODIFICATIONS: 1) THE STIMULATOR HAS BEEN MODIFIED TO INCLUDE: A) A NEW USER INTERFACE (SIMILAR TO P850022/S015). THE USER INTERFACE INCLUDES AN ALARM BUTTON, YELLOW LED, AND A LCD DISPLAY TO INDICATE TREATING STATUS; B) AN AUDIBLE AND VISIBLE SELF-CHECKING ALARM MECHANISM WITH ADDITIONAL MALFUNCTION SOURCE INDICATORS (SAME AS P850022/S015). THE AUDIBLE ALARM MECHANISM CAN BE DISABLED USING THE ALARM BUTTON; C) A NEW MAIN PCB CIRCUIT BOARD (SAME AS P850022/S015); D) SOFTWARE C PROGRAM LANGUAGE (SAME AS P850022/S015); E) AN ELAPSED TIME ACCUMULATOR/PATIENT MONITORING FUNCTION (SIMILAR TO P850022/S015). AFTER 270 DAYS OF ELAPSED TREATMENT TIME OR 400 DAYS OF TOTAL ACTIVATION TIME THE 7UNIT WILL NO LONGER GENERATE A SIGNAL. 2) THE POWER SOURCE HAS BEEN MODIFIED FROM A DISPOSABLE BATTERY TO A RECHARGEABLE NIMH "AA" BATTERY. THE DEVICE INCLUDES TWO RECHARGEABLE BATTERIES AND A SINGLE CELL BATTERY CHARGER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ORTHOPAK2 BONE GROWTH STIMULATOR SYSTEM AND IS INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECT IS LESS THAN ONE-HALF THE WIDTH OF THE BONE TO BE TREATED. A NONUNION IS CONSIDERED TO BE ESTABLISHED WHEN THE FRACTURE SITE SHOWS NO VISIBLE PROGRESSIVE SIGNS OF HEALING.

    Classifications

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

    Product Code Device Name
    LOF Stimulator, Bone Growth, Non-Invasive