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The Joline Kyphoplasty System Allevo is intended to be used for the reduction of fixation of fractures and or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethylmethacy late (PMMA) bone cements).

The Joline® Kyphoplasty System Allevo is a sterile, single-use system of instruments that facilitates balloon kyphoplasty. The subject device includes both single and double balloon catheter options that allows the introduction of one, or two balloons, into each pedicle at a time, for a total of two or four balloons per vertebrae. The balloons can be expanded or deflated separately using contrast medium, a balloon adapter, and an inflation device. The Joline® Kyphoplasty System Allevo includes instruments and accessories that facilitate the kyphoplasty procedure, including devices and curettes for creation of access channels within the bone. Subsequent to creating the cavities within the vertebral bone, the vertebral body is stabilized with an FDA cleared PMMA bone cement that cures within a few minutes. The Joline Kyphoplasty System Allevo is offered in kits that are comprised of various combinations of instruments that address surgeon preference and specific clinical condition of the patient.