Zyga Technology, Inc. Receives FDA 510(K) Clearance for the SImmetry™ Sacroiliac Joint Fusion System
MINNEAPOLIS, Jan. 18, 2011 /PRNewswire/ -- Zyga Technology, Inc. announced today that the U.S. Food & Drug Administration (FDA) has granted the company 510(K) clearance to market the SImmetry™ Sacroiliac Joint Fusion System. The SImmetry Sacroiliac Joint Fusion System is intended for treating conditions including degenerative sacroiliitis and sacroiliac joint disruptions. The SImmetry Sacroiliac Joint Fusion System consists of a range of threaded, cannulated implants and associated instrumentation. The implants are designed to transfix the sacrum and ilium, providing stability for bony fusion.
Sacroiliac joint dysfunction has been shown to be the source of pain for up to 30% of patients suffering from low back pain. Sacroiliac joint dysfunction can cause SI joint pain and is typically characterized by sacroiliac ligament pain, lower back pain, buttock pain, or pain in one or both legs. Patients who suffer from this condition typically receive SI Joint injections which temporarily address the problem but require long-term repeat treatments. Traditional, open fusion of the SI joint has been performed for decades but is limited in practice due to its complexity, high complication rate and generally poor outcomes.
According to Dr. Richard Kube, Chief of Orthopedic Surgery at Prairie Spine & Pain Institute in Peoria, IL, "SImmetry is a welcome addition to my practice because it gives patients suffering from sacroiliac joint dysfunction a minimally invasive surgical treatment option. The SImmetry system allows surgeons to prepare the SI joint for a true arthrodesis."
"We are very excited for this important milestone in our company. Increased awareness of SI joint disruption as a significant contributor to low back pain led us to develop a minimally invasive solution to treat this condition," said Robert Assell, President and CEO of Zyga Technology, Inc.
About Zyga Technology, Inc.
Based in Minneapolis, MN, Zyga Technology, Inc. was founded to develop and market innovative, minimally invasive surgical solutions to treat conditions of the spine. In addition to SImmetry the company is also developing the Glyder™ Facet Resurfacing System. Glyder is being developed as a minimally invasive technique for treating patients with facetogenic pain. Zyga has put together a team of engineers, marketing personnel, and management with significant experience developing medical devices for the spine industry.
SOURCE Zyga Technology, Inc.