Zyga wins 510(k) for Simmetry fusion system

Zyga Technology said today it won 510(k) clearance from the FDA for its Simmetry sacroiliac joint fusion system for single or 2-incision indications.

Based in Minnetonka, Minn., Zyga develops minimally invasive surgical products for the treatment of lumbar spinal conditions.

“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, 1-inch incision and to adapt the surgery to their individual anatomy and condition,”Dr. David Greenwald, M.D. of St. Augustine’s Flagler Brain and Spine Institute said in a press release.

Last December, Zyga said it raised $2 million in an equity-and-options round it hopes will eventually bring in $5 million. A year earlier in December 2013, Zyga reported raising $10 million in a funding round involving 5 undisclosed investors.

In 2013, the company said it closed enrollment in the GLISSADE study, a 40-patient clinical trial of its Glyder facet resurfacing system in treatment of chronic back pain.

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