The Mobi-C® Cervical Disc Prosthesis (Mobi-C®) is a single use device for cervical intervertebral disc replacement at one level or two contiguous levels from C3 to C7 designed to maintain/restore segmental motion and disc height. The components of the Mobi-C® include a cobalt, chromium, molybdenum (CoCrMo per ISO 5832-12) alloy superior spinal plate, an inferior CoCrMo spinal plate, and an ultra-high molecular weight polyethylene (UHMWPE per ISO 5834-2) mobile insert. The inner contact surfaces of the superior and inferior spinal plates are spherical and flat, respectively. This allows for fully congruent contact surfaces between the spinal plates and mobile insert. The two lateral stops of the inferior plate are designed to control and limit the mobility of the mobile insert. The spinal plates, both superior and inferior, feature two rows of teeth which are designed to aid in initial and long term fixation and stability. The teeth are designed to sink into the bone to facilitate endplate fixation and do not require any bone removal or chiseling prior to insertion. A titanium (per ASTM F1580) and hydroxyapatite (per ISO 13779) plasma spray coating is applied to the bony interface surfaces of the superior and inferior spinal plates.
The Mobi-C® Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following discectomy at one level or two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to the level of the disc space and at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height compared to adjacent levels. The Mobi-C® Cervical Disc Prosthesis is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the Mobi-C® Cervical Disc Prosthesis.
The Mobi-C® Cervical Disc Prosthesis should not be implanted in patients with the following conditions:
- Acute or chronic infection, systemic or at the operative site;
- Known allergy or sensitivity to the implant materials (cobalt, chromium, molybdenum, titanium, hydroxyapatite, or polyethylene);
- Compromised vertebral bodies at the index level due to previous trauma to the cervical spine or to significant cervical anatomical deformity or disease (e.g., ankylosing spondylitis, rheumatoid arthritis);
- Marked cervical instability on resting lateral or flexion/extension radiographs demonstrated by translation greater than 3.5mm, and/or > 11° angular difference to that of either adjacent level;
- Osteoporosis or osteopenia defined as DEXA bone mineral density T-score < -1.5;
- Severe facet joint disease or degeneration.