PCM Cervical Disc System

Inclusion Criteria:

• Age 18-65 years;

• Diagnosis of radiculopathy or myelopathy of the cervical spine between C3-4 and C7-T1;

• Symptomatic at only one level from C3-C4 to C7-T1;

• Unresponsive to non-operative treatment for six weeks, or has the presence ofprogressive symptoms or signs of nerve root/spinal cord compression in the face ofconservative treatment;

• Baseline NDI score of ≥30/100;

• Radiographically determined pathology at level to be treated correlating to primarysymptoms, including at least one of the following: decreased disc height, degenerativespondylosis on CT or MRI, or disc herniation;

• Appropriate for treatment using an anterior surgical approach, including having nomore than one previous anterior surgical approach to the cervical spine;

• Ability and willingness to comply with follow-up regimen; and

• Written informed consent given by subject or subject's legally authorizedrepresentative.

Exclusion Criteria:

• Infection at the site of surgery;

• History of, or anticipated treatment for, active systemic infection, including HIVinfection or hepatitis C;

• Prior attempted or completed cervical spine surgery, except (1) laminoforaminotomywith less than one-third facetectomy at any level, or (2) a successful single-levelanterior cervical fusion;

• More than one immobile vertebral level between C1-T1 from any cause, including but notlimited to congenital abnormalities, osteoarthritic "spontaneous" fusions, and priorcervical spinal fusions;

• Previous trauma to the C3-T1 levels resulting in significant bony or disco-ligamentouscervical spine injury;

• Axial neck pain in the absence of other symptoms of radiculopathy or myelopathyjustifying the need for surgical intervention;

• Radiographic confirmation of severe facet joint disease or degeneration.

• Osteoporosis:

• Severe diabetes mellitus requiring daily insulin management;

• Active malignancy: a history of any invasive malignancy (except non-melanoma skincancer), unless the patient has been treated with curative intent and there have beenno clinical signs or symptoms of the malignancy for at least 5 years;

• Tumor as source of symptoms;

• Symptomatic DDD or significant cervical spondylosis at two or more levels;

• Known or suspected allergy to cobalt, chromium, molybdenum, titanium, or polyethylene;

• Severe myelopathy to the extent that the patient is wheelchair bound;

• Pregnant (verified in patients of childbearing potential by a negative urine pregnancytest when preadmission testing is obtained), or interested in becoming pregnant duringthe duration of the study;

• Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoidarthritis; ankylosing spondylitis);

• Spinal axis disease (thoracic or lumbar) to the extent that surgical consideration islikely anticipated within 6 months after the cervical randomized procedure;

• Other degenerative joint disease (e.g. shoulder, hip, knee) to the extent thatsurgical consideration is likely anticipated within 6 months after the cervicalrandomized procedure;

• Previous spine surgery within the 6 months preceding the cervical randomizedprocedure;

• Current or recent history of substance abuse (drug or alcohol);

• Morbid obesity, defined as body mass index ("BMI") > 40 or more than 100 lbs. overideal body weight;

• Currently using, or planning to use, bone growth stimulators in the cervical spine;

• Use of any other investigational drug or medical device within the last 30 days priorto surgery

• Currently a prisoner; or

• Currently pursuing personal litigation related to the neck or cervical spine injury;however, involvement in worker's compensation related litigation is not a requiredexclusion.