About Mobi-C

• Designed by an experienced French surgeon team
• First implanted in November 2004 in France
• Entered into FDA IDE one and two-level studies in 2006
• FDA approved for use in the United States in August 2013

How does the Mobi-C move?

The Mobi-C top plate moves over the plastic insert. The plastic insert slides across and twists on the bottom plate.

The muscles and soft tissue in your neck move the vertebrae and the attached Mobi-C plates. With vertebrae and neck muscle movement, the Mobi-C is free to twist and slide left-to-right and front-to-back. This allows the vertebrae above and below the Mobi-C to move. This feature is designed to allow the disc to self-adjust and move with the spine, which is intended to facilitate motion similar to the natural cervical spine.

There are no invasive keels or screws required for Mobi-C placement. No bone chiseling eliminates operative steps and preserves the vertebrae for a stable surface ideal for one or two-level implantation.

The Mobi-C disc has three parts: two metal plates and a plastic insert in the middle. The plates are made of a mix of metals commonly used in spine surgery (cobalt, chromium, and molybdenum).

The plates have teeth on the top and bottom that help hold the plates to the vertebrae. The teeth are pressed into the bone with no bone cut out, which makes the Mobi-C design and technique bone sparing.

The outside of the metal plates are sprayed with a coating (hydroxyapatite). This coating helps the vertebrae to grow and attach to the metal plates for long term stability.

The plastic insert is made from polyethylene. The insert is flat on the bottom and round on the top. The insert is made to move as you move your neck.

Mobi-C eliminates operative steps with no bone chiseling required to cut a path for teeth or screws. After disc preparation, Mobi-C can be inserted in one step.

Mobi-C comes preassembled on a plastic cartridge. This simplifies implantation, and allows an X-ray view of the implant for optimal positioning.

Cervical Disc Replacement with Mobi-C

In a surgery with the Mobi-C Cervical Disc, the unhealthy disc is removed, but instead of a bone spacer or plastic implant along with a plate and screws, a Mobi-C is implanted into the disc space. Where a fusion procedure is intended to eliminate motion at the surgery levels, the goal of a surgery with Mobi-C is to allow motion at those levels.

Both fusion and Mobi-C artificial disc surgery:

• Replace the damaged disc.
• Try to match a healthy disc height to help un-trap any nerves.

Only the Mobi-C implant:

• Tries to maintain neck movement.
• Fits entirely within the disc space.

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.

Note: Please refer to the Mobi-C Summary of Safety and Effectiveness Data (PMA P110002, PMA P110009) at www.fda.gov for complete study results.