When used as an intervertebral body fusion device, the Zuma/Zuma-L System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autograft. Zuma/Zuma-L is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems.

When used as a Vertebral Body Replacement Device, the Zuma/Zuma-L System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Zuma/Zuma-L System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, Zuma/Zuma-L is intended for use with bone graft.

(QF-10-01-16-ENGL-B)