Zyga Technology, Inc. receives FDA 510(k) clearance for sacroiliac joint fusion system

Zyga Technology, Inc. announced the 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 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 sacroiliac 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 sacroiliac joint injections which temporarily address the problem but require long-term repeat treatments. Traditional open fusion of the sacroiliac joint has been performed for decades but is limited in practice due to its complexity, high complication rate and generally poor outcomes.

“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,” Dr. Richard Kube, chief of orthopedic surgery at Prairie Spine and Pain Institute in Peoria, Ill., stated in a company press release.

“We are very excited for this important milestone in our company. Increased awareness of sacroiliac joint disruption as a significant contributor to low back pain led us to develop a minimally invasive solution to treat this condition,” President and CEO of Zyga Technology, Inc., Robert Assell, stated in the release.