Zyga Receives 510(k) Clearance
Zyga Technology, Inc., a medical device company dedicated to the research, development, and commercialization of surgical solutions to treat conditions of the lumbar spine, recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its SImmetry® Sacroiliac Joint Fusion System using either a two-incision or a single-incision technique. The SImmetry System uses a minimally invasive surgery procedure and is designed to stabilize the sacroiliac joint.
David Greenwald, M.D. of the Flagler Brain and Spine Institute in St. Augustine, stated:
In the operating room, surgeons need as many options as possible to effectively treat each individual. . . . 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 of adults in the U.S. Accordingly, 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.