Pharmaceutical Business review

X-spine wins FDA clearance for Calix spinal implant system

The Calix spinal implant system is reportedly designed to function as a cervical intervertebral fixation device as well as a vertebral body replacement device in the thoracic and lumbar spine. The company will introduce the product on May 5, 2009.

According to X-spine, the Calix system is manufactured from Peek-Optima polymer, which enjoys widespread adoption in spinal surgery due to its excellent mechanical and biological properties. The system is believed to be X-spine’s sixth FDA-cleared spinal product.

David Kirschman, CEO of X-spine, said: “We are excited about the Calix because it represents our first product to address cervical interbody fixation. X-spine has earned tremendous growth in the anterior cervical plating market with our Spider Cervical plating system, so the addition of an interbody product to pair with it represents a great opportunity for us.”