Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease

The Freedom Lumbar Disc is indicated for spinal arthroplasty in skeletally mature patients
with single level, symptomatic degenerative disc disease (DDD) from L3-S1. This is a
prospective, multi-center, randomized, controlled trial. Subjects with DDD will be randomized
to disc arthroplasty with the FLD device or a control device. The overall purpose (objective)
of this trial is to collect clinical data to demonstrate the safety and effectiveness of FLD
used for the treatment of symptomatic lumbar degenerative disc disease compared to the
control device.

Inclusion Criteria:

- Single level, degenerative disc disease at L3 to S1, inclusive.

- Minimum of 6 months of unsuccessful conservative treatment.

- Subject is a surgical candidate for an anterior approach to the lumbar spine (<3
abdominal surgeries).

- Back pain at the operative level only (by discogram, if necessary).

- Leg pain and/or back pain due to disc space settling, with or without radicular
symptoms related to foraminal narrowing.

- Subject must understand and sign the written Informed Consent.

Exclusion Criteria:

- Prior fusion at any lumbar level.

- Clinical evidence of adjacent lumbar segment disease.

- Previous trauma to the L3, L4, L5, or S1 levels (in compression or burst).

- Non-contained or extruded herniated nucleus pulposus.

- Congenital stenosis or central/lateral stenosis (mid-sagittal stenosis of <8mm by CT
or MR) secondary to acquired degenerative disease requiring treatment that
destabilizes the spine (requiring fusion), or for subjects in whom increased motion
may increase symptoms.

- Retro- or spondylolisthesis of ≥ 2.5 mm which is either fixed or present on
flexion/extension films, and slippage of vertebral body where the listhesis is due to
disc space settling in the absence of degenerative facets or a pars interarticularis
defect.

- Significant kyphosis (>11ْ sagittal plane deformity).

- History of any invasive malignancy (except non-melanoma skin cancer) unless treated
with curative intent and there have been no clinical signs or symptoms of malignancy
for at least 5 years (in particular, spinal tumors).

- Acute or chronic infection (local or systemic).

- Instability or facet joint arthrosis, clinically significant.

- Arachnoiditis.

- Known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or
silicone.

- Radiographic findings of a fused or total collapsed disc.

- Subject using medications or drugs known to potentially interfere with bone or soft
tissue healing (high-dose of steroids, osteoclast inhibitors, etc.).

- Systemic disease affecting the spine, including rheumatoid arthritis, autoimmune
disease, AIDS, HIV, or hepatitis.

- Paget's disease, osteomalacia or any other metabolic bone disease (excluding
osteoporosis which is addressed separately).

- Psychosocial disorders (e.g. evidence or drug or alcohol abuse).

- Morbid (extreme) obesity (BMI ≥ 40 kg/m2).

- Bone growth stimulator use in spine.

- Investigational drug or device use within 30 days.

- Osteoporosis or osteopenia or metabolic bone disease as confirmed by DEXA scan if poor
bone quality is suspected (T-score < -1.0).

- If female of childbearing potential, pregnant or interested in becoming pregnant in
the next three years.

- Type 1 diabetes, and uncontrolled (or poorly controlled) Type 2 diabetes.

- Subjects with a history of implant rejection.

- Provocative discography with non-concordant pain at the operative level.

- Incarcerated subjects.

- Myelopathy.

- Significant leg pain of a radicular or neurogenic claudication nature.

- Involved vertebral endplates dimensionally smaller then 39 mm in the mediallateral
and/or 32 mm in the anterior-posterior directions.

- Subjects not able to meet follow-up requirements.

- Lumbar scoliosis > 11 degrees.

- Any previous or current litigation related to the spine.