Devices & Diagnostics

X-Spine gets FDA clearance of new spinal fusion system

Medical device maker X-Spine has obtained U.S. regulatory clearance of a new spinal fusion system. The Miamisburg, Ohio company’s AXLE-PEEK system is cleared for the treatment of degenerative disk disease and is able to be implanted through a smaller incision than competing systems, according to a statement from the company. The new system also allows […]

Medical device maker X-Spine has obtained U.S. regulatory clearance of a new spinal fusion system.

The Miamisburg, Ohio company’s AXLE-PEEK system is cleared for the treatment of degenerative disk disease and is able to be implanted through a smaller incision than competing systems, according to a statement from the company.

The new system also allows surgeons to choose between two types of materials for the implants.

“Surgeons can now decide if polymer or titanium is the best choice for their specific needs and indications,” said CEO Dr. David Kirschman. “This type of innovation exemplifies our philosophy of putting multiple treatment options into the hands of the spine surgeon and patient.”

Kirschman, a neurosurgeon and inventor, founded X-Spine in 2004, the same year it received its first product clearance from the U.S. Food and Drug Administration.

The company sells several different types of spinal systems, as well as implant materials.