Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease

Inclusion Criteria:

• Skeletally mature males or females, aged 21 to 65 years old, inclusive.
• Single, or adjacent, 2-level degenerative disc disease at C3-C7, inclusive.
• Subject is a surgical candidate for an anterior approach to the cervical spine.
• Minimum of 6 weeks of unsuccessful conservative treatment.
• Subject with at least moderate preoperative pain and functional impairment
• Subject is mentally and physically able to comply with protocol, postoperative compliance instructions, and follow-up schedule through 2-years.
• Subject must understand and sign the written Informed Consent form.

Exclusion Criteria:

• Subject with axial neck pain only who does not demonstrate concurrent arm pain or progressive neurological deterioration (specifically numbness or muscle weakness in the arm).
• An active infection at the operative site or active systemic infection at the time of surgery.
• Known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or silicone.
• Previous spinal fusion at the involved, or adjacent, cervical level(s).
• Congenital or acquired structural defect at the operative levels (s) or their immediately adjacent level(s).
• Significant osteoporosis in the cervical spine.
• The investigator should assess if the subject has any of the following conditions at the index or adjacent level(s) which excludes the subject from study participation:
• Cervical facet degeneration of the involved C3-C7 levels.
• Previous trauma to, or fusion in, the C3-C7 levels.
• Cervical instability at the index level(s) on neutral lateral or flexion/extension x-rays.
• Radiographic findings of a fused or total collapsed disc.
• Significant global cervical kyphosis (≥15º on Cobb angle measurement) or significant reversal of lordosis.
• Female of childbearing potential, pregnant, breast feeding, or interested in becoming pregnant in the next two years