Dynesys Spinal System Post Market 522 Study

Study is meant to assess the safety and fusion rates following posterior lateral fusion with
the Dynesys Spinal System.

Inclusion Criteria:

1. Skeletally mature between the ages of 20-80

2. Candidate for posterior lateral fusion between T1-S1 with autograft

3. Degenerative spondylolisthesis with evidence of neurologic impairment or failed
previous fusion (pseudoarthrosis)

4. Symptoms of leg and/or back pain

5. Non-responsive to conservative/non-surgical treatment for at least three (3) months

6. Must be willing and able to comply with study requirements; including complete
necessary study paperwork and return for required follow-up visits

Exclusion Criteria:

1. Active systemic or local infection

2. Obesity

3. Use of interbody device

4. Pregnancy

5. Mental illness

6. Incarceration

7. Alcohol or drug abuse

8. Severe osteoporosis or osteopenia

9. Use in the cervical spine

10. Sensitivities/allergy to metals, polymers, polyethylene, polycarbonate urethane and
polyethylene terephthalate

11. Soft tissue deficit not allowing sound closure

12. Any medical or physical condition that would preclude the potential benefit of spinal
implant surgery

13. Congenital abnormalities, tumors or other conditions that would prevent secure
component fixation that has the potential to decrease the useful life of the device

14. Active malignancy or other significant medical comorbidities

15. Any medical or mental condition which would put the patient at high risk due to the
severity of surgery

16. Inadequate pedicles of the thoracic, lumbar and sacral vertebrae

17. Patient unwilling or unable to follow postoperative instructions