K2M Group’s next-generation Rhine cervical disc system gets CE Mark

21 January 2016 (Last Updated January 21st, 2016 18:30)

US-based K2M Group Holdings has received CE Mark approval for its next-generation Rhine cervical disc system to market in Europe and other countries.

US-based K2M Group Holdings has received CE Mark approval for its next-generation Rhine cervical disc system to market in Europe and other countries.

The company has developed the next-generation cervical artificial disc replacement for the treatment of degenerative disc disease.

The system features one-piece compressible polymer core design with dome-shaped, plasma-coated endplates and central-split keel.

The firm's moulding technology has been integrated into the Rhine cervical disc system to minimise wear between the polymer core and metal endplates.

Principal Inventor of the Rhine cervical disc system and orthopedic surgeon Dr Casey Lee said: "The Rhine cervical disc system is manufactured through a proprietary over-moulding process of elastomeric polymer that differentiates the system from the competitive offering.

"The first single and multi-level surgical procedures using the Rhine system were recently completed in Belgium and Germany."

"We are committed to showing successful clinical results and are initiating a prospective observational clinical study in multiple sites throughout Europe."

The streamlined instrumentation of the system is said to simplify the surgical technique by incorporating trialing and keel cutting into one instrument.

K2M Group Holdings president and CEO Eric Major said: "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.

"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."

The company said that the first single and multi-level surgical procedures using the Rhine system were recently completed in Belgium and Germany.

In addition, patient enrolment for a prospective, observational Rhine cervical disc clinical trial will start in the first quarter of this year.

The trial's primary objectives will be to obtain operative data and feedback, confirm device performance and collect radiographic data and clinical outcomes.

A total of 166 participants are expected to be enrolled in the trial at multiple clinical trial sites throughout Europe.

In December, the company secured 510(k) clearance and CE Mark approval for its Everest minimally invasive (MI) XT spinal system.

Everest is a cannulated top-loading pedicle screw system that features rigid closed-top break-off extension tabs for minimally invasive rod passage.