K2M Receives CE Mark for Its Next-Generation RHINE Cervical Disc System

K2M Group Holdings Inc. has received a CE Mark for the RHINE Cervical Disc System, the company’s next-generation cervical artificial disc replacement featuring proprietary molding technology.

The RHINE Cervical Disc System features a one-piece compressible polymer core design with dome-shaped, plasma-coated endplates and a central-split keel. Proprietary molding technology is incorporated to minimize wear between the polymer core and metal endplates, company executives said.

“The RHINE Cervical Disc System is manufactured through a proprietary over-molding process of elastomeric polymer that differentiates the system from the competitive offering,” said Dr. Casey Lee, orthopedic surgeon and principal inventor of the RHINE Cervical Disc System. “We are committed to showing successful clinical results and are initiating a prospective observational clinical study in multiple sites throughout Europe.”

The system’s streamlined instrumentation simplifies the surgical technique by integrating trialing and keel cutting into one instrument. A built-in adjustable stop allows for customized anterior or posterior positioning of the disc based on surgeon preference.

“The RHINE Cervical Disc System was developed through collaboration with a global surgeon design team,” said Dr. Richard Guyer, orthopedic surgeon, co-founder of the Texas Back Institute, and director of the Spine Fellowship Program in Roanoke, Texas. “The one-piece compressible polymer core design performed well in biomechanical testing when compared to the natural cervical disc, and this European launch represents evolution in cervical disc technology.”

The first single- and multi-level surgical procedures using the RHINE Cervical Disc System were recently completed in Belgium and Germany. Additionally, enrollment for a prospective, observational RHINE Cervical Disc Clinical Study will begin in the first quarter of 2016. Primary objectives of the study are to obtain operative data and feedback; confirm device performance; and collect radiographic data and clinical outcomes. An estimated 166 participants are expected to be enrolled in the study at multiple clinical trial sites throughout Europe.

“We are excited to receive a CE Mark for our RHINE Cervical Disc technology, as it represents an important regulatory milestone event for K2M as we continue to build our product portfolio and penetrate the global spine market with innovative techniques and technologies,” said Eric Major, K2M’s president/CEO. “We look forward to further expanding our international product offering and will remain focused on the complex spine category across all of our international markets.”

Based in Leesburg, Va., K2M Group Holdings Inc. designs, develops and commercializes complex spine and minimally invasive spine technologies and techniques.