ZimVie Announces Over 200,000 Cervical Discs Have Been Replaced with Mobi-C.

Mobi-C Cervical Disc was the first cervical disc in the United States approved to treat more than one level of the cervical spine. Mobi-C was determined by the FDA to be statistically superior to fusion at 7 years  for two-level cervical disc replacement, based on the primary study endpoint of a prospective, concurrently controlled and randomized, multi-center clinical trial.1  At 10 years, all patient-reported outcomes were equivalent to or improved from 7 years.3.4

Mobi-C Clinical Trial Results

Mobi-C was first implanted in Europe in November 2004. 

To receive approval in the United States, an Investigational Device Exemption (IDE) clinical trial was conducted involving 599 patients that began in April 2006. This study compared Mobi-C to the current standard of care, anterior cervical discectomy and fusion (ACDF), for both one and two-level indications.

Mobi-C Clinical Summaries

IDE Clinical Trial Overview


Mobi-C Compared to Anterior Cervical Discectomy and Fusion at One-level

IDE Clinical Trial Overview


Mobi-C Compared to Anterior Cervical Discectomy and Fusion at Two Contiguos Level 

Ten-Year Outcomes of 1- & 2-Level Mobi-C Patients


Extended Follow-Up from the Mobi-C IDE Study

   

Mobile Bearing Technology

Controlled Mobility

Restoring natural motion to the cervical spine 

The controlled mobility of the patented mobile core is the foundation of Mobi-C. With vertebrae and neck muscle movement, the Mobi-C implant is free to twist and slide left-to-right, and front-to-back, as well as rotate.

Self-Adjusting

A return to physiological mobility

The center of rotation at each level of the cervical spine is variable and constantly changing.4 Mobi-C was designed to adapt to the Instantaneous Axis of Rotation through its self-adjusting mobile core. The mobile core allows the vertebrae above and below the disc to move, to maintain normal neck motion. 

Mobi-C moves with the spine and does not dictate a predetermined,  fixed axis of rotation. This facilitates independent and coupled motion similar to natural cervical spine motion.

Mobi-C Self-Adjusting

Mobi-C is composed of three parts: two metal plates and a medical grade polyethylene insert in between. The top plate rotates over the domed insert, allowing for a continuous path of cyclic movements: Flexion-Extension (FE), Lateral Bending (LB), and Axial Rotation (AR).

Mobi-C Self-Adjusting Image
Mobi-C Self-Adjusting Image

Ease of Insertion

One-Step Insertion

To insert the Mobi-C Cervical Disc, no additional exposure or operative steps are required for screw or keel placement, eliminating the need for drilling or chiseling.

Mobi-C Ease of Insertion Image
Mobi-C Ease of Insertion Image
Mobi-C Ease of Insertion Image

   

Pre-assembled Implants

Mobi-C is delivered pre-assembled on a disposable PEEK cartridge. The cartridge assembles easily to the implant inserter, saving operative steps.

Mobi-C Pre-assembled Implants
Mobi-C Pre-assembled Implants

The PEEK Cartridge allows a radiolucent view of the implant for optimal positioning.

Bone Sparing

No Bone Chiseling

Preserves Bone Surface

Mobi-C's mobile core is designed to create low stress at the implant to bone interface. Implantation of the Mobi-C requires no invasive keels or screws, no bone removal for keel preparation, and no additional operative steps for keel cutting. 

Intact endplates, compared to endplates prepared for keels, provide a couple of benefits:

  • Preserved surface for the implant, ideal for two-level implantation
  • Intraoperative flexibility to optimize implant positioning
Mobi-C Bone Sparing
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Important Information

Mobi-C is the first cervical disc FDA approved for both one and two-level indications. The U.S. Food and Drug Administration (FDA) approved an update to the Mobi-C labeling to include seven-year clinical results.

Additional Information

To request a paper copy of the Instructions for Use, contact ZimVie Spine Customer Service