OBJECTIVE: Two-dimensional fluoroscopy-based computerized navigation for the placement of pedicle screws offers the advantage of using stored patient-specific imaging data in providing real-time guidance during screw placement. The study aimed to describe the accuracy and reliability of a fluoroscopy-based navigation system for pedicle screw insertion. METHODS: A total of 477 pedicle screws were inserted in the lower back of 96 consecutive patients between October 2007 and June 2012 using fluoroscopy-based computer-assisted surgery. The accuracy of screw placement was evaluated using a sophisticated computed tomography protocol. RESULTS: Of the 477 pedicle screws, 461 (96.7%) were judged to be inserted correctly. Frank screw misplacement [16 screws (3.3%)] was observed in 15 patients. Of these, 8 were classified as minimally misplaced (< or =2 mm); 3, as moderately misplaced (2.1-4 mm); and 5, as severely misplaced (>4 mm). No complications, including nerve root injury, cerebrospinal fluid leakage, or internal organ injury, were observed in any of the patients. CONCLUSION: The accuracy of pedicle screw placement using a fluoroscopy-based computer navigation system was observed to be superior to that obtained with conventional techniques.