CE Mark for K2M’s Next-Generation Cervical Disc System

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01/02/2016

Complex spine specialist K2M Group Holdings, Inc., says it has received a CE Mark for the RHINE™ Cervical Disc System which it describes as its next-generation cervical artificial disc replacement featuring proprietary molding technology.

Background

K2M designs, develops and commercializes innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies.

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.

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 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. An estimated 166 participants are expected to be enrolled in the study at multiple clinical trial sites throughout Europe.


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