Medical device firm K2M Group Holdings has received CE mark approval for its next-generation Rhine cervical disc system to market within Europe and other countries.
K2M has developed 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 molding technology is integrated into the system to minimize wear between the polymer core and metal endplates.
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."
Rhine’s streamlined instrumentation is said to simplify the surgical technique by incorporating trialing and keel cutting into one instrument.
According to the company, the first single and multi-level surgical procedures using the Rhine system were recently completed in Belgium and Germany
Last December, K2M Group received 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.