BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P850007 · Supplement: S027 · Decision Apr 5, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 AND SPINAL-STIM LODEL 2212
    PMA Number
    P850007
    Supplement Number
    S027
    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
    April 5, 2005
    Date Received
    June 4, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE PHYSIO-STIM LITE, MODELS 202L, 303L, 215L, 313L, 314L AND SPINAL-STIM MODELS 212L AND 212LE AS FOLLOWS: 1) CHANGE THE POWER SOURCE FROM A 9-VOLT DISPOSABLE BATTERY TO AN 11.1-VOLT RECHARGEABLE; 2) CHANGE THE USER INTERFACE FROM A THREE COLOR LED TO A BACKLIT LCD DISPLAY; 3) CHANGE THE CIRCUIT ASSEMBLY FROM SEPARATE BOARDS FOR THE DRIVE CIRCUIT AND MICROCONTROLLER TO A SINGLE BOARD; 4) ADD AN OPTIONAL PERSONAL DATA ASSISTANT (PDA) THAT MAY BE USED TO SET DAILY SHUTDOWN TIME FOR ORTHOFIX PERSONNEL USE ONLY; AND 5) CHANGE THE SERIAL PORT CABLE ON THE COMPLIANCE PRINTER TO AN INFRARED PORT. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PHYSIO-STIM MODELS 3202, 3302, 3313, 3314, 3315 ANDSPINAL-STIM MODEL 2212. THE PHYSIO-STIM MODELS ARE INDICATED FOR THE TREATMENT OF AN ESTABLISHED NONUNION ACQUIRED SECONDARY TO TRAUMA, EXCLUDING VERTEBRAE AND ALL FLAT BONES, WHERE THE WIDTH OF THE NONUNION DEFECTS 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 VISIBLY PROGRESSIVE SIGNS OF HEALING. THE SPINAL-STIM IS A NONINVASIVE ELECTROMAGNETIC BONE GROWTH STIMULATOR INDICATED AS A SPINAL FUSION ADJUNCT TO INCREASE THE PROBABILITY OF FUSION SUCCESS AND AS A NONOPERATIVE TREATMENT FOR SALVAGE OF FAILED SPINAL FUSION, WHERE A MINIMUM OF NINE MONTHS HAS ELAPSED SINCE LAST SURGERY.

    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