Zyga receives 510(k) clearance for SImmetry sacroiliac joint fusion system updates


Zyga Technology has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the SImmetry system using either a two-incision or a single-incision technique.

“In the operating room, surgeons need as many options as possible to effectively treat each individual,” said David Greenwald, of the Flagler Brain and Spine Institute in St. Augustine, USA. “This new SImmetry technique allows me to offer patients a single, one-inch incision and to adapt the surgery to their individual anatomy and condition.”

The Centers for Disease Control and Prevention lists low back pain as the second most common cause of disability in US adults. It has been reported that approximately 20% of all chronic low back pain derives from the sacroiliac joint. In January 2015, the Centers for Medicare and Medicaid Services assigned a Category 1 CPT code to minimally invasive sacroiliac joint fusion, improving patient access to the procedure.