FDA clears Axle-Peek interspinous fusion system for treatment of disc disease


The US Food and Drug Administration (FDA) has cleared the Axle-Peek interspinous fusion system (X-spine) for the treatment of degenerative disc disease. 

The system expands on X-spine’s Axle line of interspinous fusion devices by incorporating an insert manufactured from Peek-Optima provided by Invibio Biomaterial Solutions. The Axle-Peek implants can be placed through a smaller incision and with less disruption of tissues than traditional spinal fusion devices. With this clearance, spine surgeons have a choice of implant materials, either titanium or polymer, in a single device.

“The proprietary modular design of the Axle system allows for different types of inserts to be placed in the interspinous space. Surgeons can now decide if polymer or titanium is the best choice for their specific needs and indications,” said David Kirschman, president and CEO of X-spine. “This type of innovation exemplifies our philosophy of putting multiple treatment options into the hands of the spine surgeon and patient.”