FDA 510(k) Clearance for Zyga SImmetry® Sacroiliac Joint Fusion System Updates

Spinal device company Zyga Technology, Inc., says it has received U.S. FDA 510(k) clearance for its SImmetry System that will allow physicians to perform SI joint fusion in the most appropriate, minimally invasive fashion.


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

Zyga Technology, Inc. is marketing the SImmetry® Sacroiliac Joint Fusion System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis. This new clearance means the company can now market its system for use with either a two-incision or a single-incision technique.

Physician comments

“In the operating room, surgeons need as many options as possible to effectively treat each individual,” said David Greenwald, M.D. of the Flagler Brain and Spine Institute in St. Augustine. “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.”

Source: PR Newswire

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