X-Spine gets FDA clearance for spinal fusion system

Spinal implants and surgical instruments maker X-spine Systems Inc. has received regulatory clearance to begin selling a spinal fusion system.

The company’s Axle system is designed to provide spinal stability for lumbar fusion procedures, according to a statement from Miamisburg, Ohio-based X-spine.

The device can be implanted through a one-inch incision in a patient’s back. It works by attaching to the rearmost portion of adjacent vertebrae in the lower or middle spine, according to the statement.

X-spine has 10 products that have received clearance from the U.S. Food and Drug Administration, with the first — a cervical plating system — coming in 2004.

The company was founded in 2003 by CEO Dr. David Kirschman, a neurosurgeon and inventor.