X-Spine Gets CE Mark, Signs Distribution Deal

X-spine Systems, a four-year-old company from Miamisburg, OH, has been given permission to expand into Europe, after receiving CE Mark approval for its Capless and Spider Cervical spinal implant products. Both products are already FDA cleared, and are being marketed in South Africa as well.

The Capless Pedicle Screw System incorporates a proprietary rotary locking mechanism which affixes the rod in place without a separate cap or setscrew. Elimination of the locking cap allows for faster surgeries, without the possibility of cap loosening, cap loss, or cross threading which is endemic to traditional screw systems. It also means fewer parts to stock and inventory, which results in cost savings.

The Spider Cervical Plating System consists of a cervical fixation plate with a patented resilient arm” locking mechanism to prevent screw back-out. The Spider Cervical plating system eliminates false screw locking by providing positive auditory, tactile and visual feedback to the surgeon. These factors confirm screw locking without requiring any additional locking steps.

In conjunction with the CE Mark milestone, X-spine inked a deal with Highland Medical Ltd. of Oxfordshire, U.K., to be the exclusive distributor of X-spine products in the U.K.

X-spine prides itself on its surgeon-centric philosophy. The company says its products are designed by surgeons who consult with engineers, not the other way around. The goal is to create spinal alternatives to the me-too products that currently dominate the market.

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