Safety and Efficacy of the CarboClear Pedicle Screw System

A prospective, multi-center, confirmatory, single arm, study. Results of the study will be compared to data from the literature. The CarboClear Pedicle Screw System is designed for use with intervertebral body fusion device and with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, using PLIF or TLIF. A total of 55 subjects will participate in the study, with up to 25 patients recruited at sites in Israel and at least 30 patients will be enrolled in US sites. Follow-ups: Radiographic (AP, lateral and flexion/extension X-Rays) and clinical evaluations. Follow-up sessions at 6 weeks, 3 months, 6 months, 12 months, and 24 months postoperatively, and then annually, until the last patient has completed 2-year follow-up.