A Pivotal Study of a Facet Replacement System to Treat Spinal Stenosis

Spinal Stenosis continues to be a major cause of back and leg pain. The condition is
attributed to narrowing of the space around the nerves in the lumbar spine. This is often
caused by the degenerative process in the spine and the facet joints. The current treatment
calls for removal of bone around the affected nerve including the facet joints and fusing the
posterior of the spine to ensure the segments remain stable.

The ACADIA® Facet Replacement System (AFRS) allows for an anatomic reconstruction of the
facet joint after decompression and removal of the degenerated facet. Like the original facet
joint, the replacement implant is designed to reproduce facet motion while restoring normal
stability and motion.

The ACADIA® Facet Replacement System (AFRS) has been designed on the principals that have
allowed other total joint replacement procedures to provide significant patient benefits.
These guiding principals include:

- Anatomically based implant design

- Reproducible surgical technique

- Elimination of pain

The ACADIA® Facet Replacement System allows the surgeon to remove the offending bone while
preserving the motion of the facet joint.

This study will evaluate the outcomes of patients using the AFRS™ investigation compared to
those receiving instrumented posterior fusion procedure. Patients will be required to
complete study visits before the procedure and at 6 weeks, 3, 6, 12, 24 months post procedure
and annually thereafter as required by FDA. Follow up visits consist of administration of
questionnaires, radiographs and neurological assessment.

Inclusion Criteria:

- 21-85 years of age and skeletally mature;

- Have undergone 6 months of non-operative treatment prior to surgery;

- Lateral, lateral recess and/or central canal stenosis;

- Disc height measuring ≥ 4 mm at the operative level;

- Persistent leg, thigh and/or buttock symptoms,including pain,numbness, burning or
tingling with a minimum leg pain score of 40mm as measured with the Visual Analogue
Scale (VAS) Index;

- A score greater than 2 on a scale of 1-5 on the Zurich Claudication Questionnaire
(ZCQ) Symptom Severity (SS) Score-Candidate;

- A score greater than or equal to 2 on a scale of 1-4 on the ZCQ Physical Function (PF)
Score;

- A candidate for a decompression with full facetectomy at the operative level

- Candidate for a posterior lumbar fusion;

- Physically and mentally willing and able to comply evaluations;

- Lives in the immediate area and has no plans to relocate;

Exclusion Criteria:

- Previous surgical procedure at the operative or adjacent level except for one of the
following: Micro-discectomy, laminectomy, lamino/foraminotomy, rhizotomy, IDET, and/or
interspinous spacer;

- Previous lumbar fusion or disc replacement procedure;

- Osteoporosis;

- greater than Grade I spondylolisthesis or retrolisthesis;

- Spondylolisthesis at levels other than at the operative level;

- Scoliosis of the lumbar spine (defined as more than 11 deg Cobb angle) as indicated by
plain X-ray films;

- Primary diagnosis of discogenic back pain due to torn, herniated, inflamed or
irritated disc or other pathology where the patient exhibits axial back pain from
degenerative disc disease;

- Acute traumatic pars fracture at the operative/adjacent level vertebral body;

- Spinal stenosis at more than three lumbar segments;

- Acute trauma to the lumbar spine within the last 24 months;

- Active infection at the operative level, or a systemic infection;

- Physically / mentally compromised;

- Systemic disease that would affect the patient's welfare or the research study.

- Immunologically suppressed or immunocompromised;

- Insulin-Dependent Diabetes Mellitus (Type I Diabetes);

- Currently undergoing long-term steroid therapy;

- Metabolic bone disease;

- Active malignancy: (except non-melanoma skin cancer), unless treated with no clinical
signs or symptoms of the malignancy for at least 5 years;

- Known allergy to cobalt chromium or titanium;

- Used any investigational drug or device within the past 30 days;

- Pending litigation related to back pain or injury;

- Is a prisoner.