Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

This is a prospective, non-randomized post market study designed to evaluate fusion and pain
reduction following the use of the SImmetry System. This study will be conducted at up to 40
sites and 250 total subjects will be enrolled and followed through 24 months. Data will be
collected pre-operatively, implant, and at specified follow-up time points through 24 months.

Key Inclusion Criteria:

- At least three positive provocative tests for SIJ pain

- Non-operative management of SIJ pain for ≥ 6 months prior to surgery

- At least one positive diagnostic SIJ injection resulting in a ≥ 50% decrease in pain

- VAS back pain score of ≥ 60 mm

- The subject is at least 18 years of age

Key Exclusion Criteria:

- Trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading
to a neurological deficit, or pelvic soft tissue or bony tumors

- Pregnant or is planning on becoming pregnant in the next two years

- Chemical dependency abuse problems as evidenced by a history of abusing drugs which is
documented in their past medical history or is elicited from an interview.

- Receiving or seeking worker's compensation, disability remuneration, and/or involved
in litigation related to low back or SIJ pain

- History of significant emotional or psychosocial disturbance