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510(k) Data Aggregation

    K Number
    K012916
    Device Name
    FRONTIER ANTERIOR SCOLIOSIS SYSTEM
    Manufacturer
    DEPUY ACROMED, INC.
    Date Cleared
    2001-11-27

    (89 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEPUY ACROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FRONTIER Anterior Scoliosis System is intended for anterolateral screw fixation to the T4 to L4 levels of the spine, with all metal at least 1 cm from a major vessel. The FRONTIER Anterior Scoliosis System may be used in either thoracoscopic procedures or open procedures. The FRONTIER Anterior Scoliosis System is intended to provide temporary stabilization as an adjunct to spinal bone grafting processes. Specific indications are: 1. Idiopathic scoliosis. 2. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). 3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele. 4. Neuromuscular scoliosis/kyphoscoliosis. 5. Spinal fractures (acute reduction or late deformity). 6. Revision surgery. 7. Tumor. The FRONTIER Anterior Scoliosis System can also be used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Indications for these scoliotic uses include: 1. Collapsing and unstable paralytic deformity. 2. Progressively increasing scoliosis. 3. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse. 4. Inability to maintain sitting balance, necessitating the use of hands. 5. Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
    Device Description
    The FRONTIER Anterior Scoliosis System consists of spinal rods, spinal screws, spinal staples, and spinal washers. The implants of the FRONTIER Anterior Scoliosis System have been designed for use in either open or thoracoscopic approaches.
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