CEM-Plate and CEM-Cage First-In-Human Use Efficacy Study

Inclusion Criteria:

1. Males and females aged 22-79 years.

2. Documented diagnosis of cervical spine radiculopathy or myelopathy.

3. Symptomatic cervical degenerative disc disease at 2 contiguous levels between C2through T1.

4. Baseline NDI score ≥30 and/or baseline mJOA score ≤16.

5. Pathology at the level to be treated correlating to the primary symptoms confirmedby imaging (computed tomography (CT), CT myelography, magnetic resonance imaging (MRI), or plain radiography).

6. Unresponsive to non-operative, conservative treatment for at least 6 weeks fromsymptom onset or presence of progressive cervical myelopathy or signs of nerveroot/spinal cord compression despite continued non-operative treatment.

7. Ability to speak, read, and understand the IRB approved Informed Consent document.

8. Willingness to give informed consent for participation in the study.

Exclusion Criteria:

1. Any prior cervical surgeries at the symptomatic levels; prior surgery or cervicalfusion procedure at any level.

2. Fewer than 2 or more than 2 vertebral levels requiring treatment.

3. Anatomy that is non-conducive to receiving investigational device.

4. More than one immobile vertebral level between C-1 to C-7 from any cause, includingbut not limited to congenital abnormalities and osteoarthritic "spontaneous"fusions.

5. Known diagnosis of osteoporosis, current pharmacological treatment for osteoporosisor bone density which in the medical opinion of the surgeon precludes operation orcontraindicates instrumentation.

6. Paget disease, osteomalacia, or any other metabolic bone disease other thanosteoporosis.

7. Active malignancy that includes a history of any invasive malignancy (exceptnonmelanoma skin cancer), unless previously treated with curative intent and with noclinical signs or symptoms of the malignancy for > 5 years.

8. Severe cervical instability based on radiographic exam (whereby an anterior andposterior reconstructive procedure is indicated).

9. Decompression requiring corpectomy at one or more levels.

10. Active systemic infection or an infection localized to the site of the proposedimplantation.

11. Open wounds.

12. Signs of local inflammation.

13. Fever.

14. Any diseases or conditions that would preclude accurate clinical evaluation.

15. Daily, high-dose oral and/or inhaled steroids or a history of chronic use ofhigh-dose steroids.

16. BMI > 40.

17. Use of any other investigational drug or medical device within 30 days prior tosurgery.

18. Smoking more than 1 pack of cigarettes/day.

19. Mental illness that, in the opinion of the investigator, would preclude patient'sability to participate in the study.

20. Current or recent history of substance abuse (alcoholism and/or narcotic addiction)requiring intervention.

21. Litigation relating to spinal injury/worker's compensation.

22. Reported to have a history of or anticipated treatment for active systemicinfection, including human immunodeficiency virus (HIV) or Hepatitis C.

23. Previous trauma to the C2 to T1 levels resulting in significant bony ordisco-ligamentous cervical spine injury.

24. Axial neck pain in the absence of other symptoms of radiculopathy ormyeloradiculopathy or myelopathy justifying the need for surgical intervention.

25. Pregnancy.

26. Any medical or surgical condition which would preclude the potential benefit ofspinal implant surgery, such as the elevation of sedimentation rate unexplained byother diseases, elevation of white blood count (WBC), or a marked left shift in theWBC differential count.

27. Suspected or documented metal allergy or intolerance.

28. Inadequate tissue coverage over the operative site or where there is inadequate bonestock, bone quality, or anatomical definition.

29. Any patient unwilling to cooperate with the post-operative instructions.

30. Any time implant utilization would interfere with anatomical structures or expectedphysiological performance.