ZimVie’s Mobi-C Cervical Disc breaks new ground with FDA approval for compact design

USA —US-based medical innovator ZimVie has garnered coveted approval from the US Food and Drug Administration (FDA) for a reduced height variant of the Mobi-C Cervical Disc, encompassing seven footprints tailored to meet the unique anatomical needs of American patients.

The Mobi-C Cervical Disc, crafted from a mobile-bearing cobalt-chromium alloy and polyethylene prosthesis, has garnered acclaim for its groundbreaking design, streamlining implantation into a singular step.

What sets this innovation apart is its omission of the need for bone chiseling or conventional vertebral anchors, such as screws or keels.

One of the standout attributes of this implant is its distinction as the first FDA-approved cervical disc prosthesis for addressing cervical disc issues spanning both single and dual levels (C3-C7).

This groundbreaking accomplishment marks a pivotal stride in the realm of spinal healthcare.

Orthopedic spine surgeon Jad Khalil of Michigan Orthopaedic Surgeons underscores the significance of the recently approved 4.5mm height implants, stating, “The addition of these implants is a pivotal enhancement to the Mobi-C lineup. Surgeons will now be equipped to navigate significantly collapsed discs more effectively, mitigating over-distraction of the facet joints.

“This expansion of capabilities for cervical disc arthroplasty holds the promise of extending the benefits of the Mobi-C Cervical Disc to a broader patient base.”

Originating as a spin-off from the Dental and Spine divisions of Zimmer Biomet, ZimVie’s Mobi-C device has enjoyed extensive utilization in France for cervical disc replacement in both single and contiguous dual levels since 2004.

It entered the US market in 2013 as the inaugural cervical disc approved by the FDA for addressing both single and dual levels.

The Mobi-C Cervical Disc Prosthesis is meticulously designed to facilitate disc reconstruction from C3-C7 in skeletally mature patients who have undergone discectomy for intractable radiculopathy. This condition may manifest with or without neck pain or myelopathy.

ZimVie Spine’s global president, Rebecca Whitney, lauds the approval of the 4.5mm Mobi-C as a triumph for surgeons and patients alike.

It also stands as a testament to the strategic prowess of their global Regulatory Affairs team, who harnessed real-world clinical evidence from EU studies to substantiate the long-term safety and efficacy of the smaller disc.

Whitney affirms, “We are thrilled to empower surgeons with an extensive array of footprint and height options, providing unparalleled motion preservation solutions to their patients.

“The imminent commercialization of this product in the US this fall underscores our commitment to elevating spinal health.”

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