Spinal implants and surgical instrument developer X-spine Systems Inc. received 510(k) clearance from the Food & Drug Administration to begin selling a spinal fusion system.
The Axle system is designed to provide spinal stability for lumbar fusion procedures, according to the company.
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, X-Spine said in a release.
The Miamisburg, Ohio-based company has 10 products that have received clearance from the FDA, with the first — a cervical plating system — arriving in 2004.
X-spine was founded in 2003 by CEO Dr. David Kirschman, a neurosurgeon and inventor.