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The Soteira Shield Kyphoplasty System (SKS) is intended to provide control of cement flow during injection of PMMA bone cement that has been cleared for use in vertebral augmentation for the treatment of acute, persistently painful (after a minimum of 6 weeks of conservative care), stable, anterior column osteoporotic compression fractures (wedge or concave) of the vertebrae at levels T4 - L5 in the adult spine.

The Soteira Shield Kyphoplasty System consists of a cement director (permanent implant), a delivery system (used to place the cement director within the vertebral body) and instruments that are used to achieve percutaneous access to the vertebral body and to create a cavity into which the cement director implant will be placed. The system is intended for use with commercially available PMMA bone cement.