SI Joint Fusion and Decortication Using the SImmetry System

This is a prospective, non-randomized post market study designed to collect data on SI joint
fusion and subject back pain following implant of the SImmetry device. The study will be
conducted at a single site and 25 subjects will be implanted and followed through 24 months.
Data will be collected pre-operatively, implant, and at specified follow-up time points
through 24 months.

Inclusion Criteria:

- Subjects must be indicated for the SImmetry device according to the approved SImmetry
labeling

- Subject has two (2) positive (experiences pain) Provocative Tests for SIJ pain; for
example, Compression, Thigh Thrust, FABER, Distraction or Gaenslen's

- Subject has documentation of failed, non-operative management of SIJ pain for ≥ 6
months prior to surgery; for example, use of medications, braces, SI belts, orthotics,
physical therapy or manual manipulation

- The subject has two (2) diagnostic SIJ injection at least one (1) resulting in a ≥50%
decrease in pain in the joint(s) from the anesthetic portion of the injection

- The subject has VAS back pain score of ≥ 50 mm

- The subject is at least 18 years of age and skeletally mature

- The subject agrees and is able to comply with study requirements

Exclusion Criteria:

- Subjects contraindicated per the cleared labeling will be excluded from participation
in the study

- The subject has pelvic soft tissue or bony tumors

- The subject has had any trauma causing fracture of the sacrum or iliac bones or has
had spinal trauma leading to a neurological deficit

- The subject has a history of a central nervous system (CNS) disorder(s)

- The subject is indicated for or awaiting other spine surgery

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

- The subject has uncontrolled insulin dependent diabetes mellitus (Type 1 Diabetes)

- The subject has 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

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

- The subject has a history of significant emotional or psychosocial disturbance
(untreated or uncontrolled anxiety attacks, obsessive/compulsive disorders, depression
or schizophrenia) as documented in their past medical history or elicited by an
interview