Nexxt Spine News & Events
Honour Spacer System Receives FDA Clearance
July 30, 2012 | Indianapolis, IN
Nexxt Spine LLC, a privately held spinal implant and instrumentation manufacturer, has announced the U.S. controlled market release of the HONOUR™ Spacer System after receiving 510(k) clearance from the United States Food & Drug Administration (FDA). The new addition to the company’s growing portfolio is designed to help provide stability for spinal fusion after a diseased disc is surgically removed.
Spacers are small, hollow devices made of polymer, packed with bone graft and inserted into the intervertebral space. The purpose of using spacers is often to restore lost disc height resulting from a collapsed disc and to relieve pressure on nerve roots, while providing positive mechanical stabilization of the vertebrae. The graft window of the spacer is packed with bone creating an environment in which natural bone growth can occur and aid the fusion of the vertebral segments.
The HONOUR™ Spacer System is a collection of radiolucent cage devices constructed of medical grade Zeniva® polyetheretherketone (PEEK) with tantalum markers for optimal intraoperative positioning. The implant family includes TLIF, tPLIF and cervical spacers; the line of implants includes various heights and footprints to accommodate individual patient anatomy and to maximize bone graft material volume. The system is versatile enough to accommodate unilateral (TLIF and oblique) and bilateral (PLIF) approaches in the lumbar spine with the option to insert directly or initially on its side to prevent over distraction of the ligamentous and nerve structure.
Andy Elsbury, President of Nexxt Spine, stated, “The Honour Spacer System is just one of several forthcoming product lines designed for ease of use and better clinical outcomes, while accommodating both traditional and direct selling channels.”