Spinal tools company Zyga Technology Inc. received Food & Drug Administration 5100(k) clearance for its SImmetry Sacroiliac Joint Fusion System.
The device is designed for minimally invasive surgery to eliminate lower back pain by stabilizing the sacrum — vertebrae at the base of the spine which connect the spine to the pelvis.
In its FDA application, the company compared its titanium bone screw device to existing products by Switerzerland-based Synthes, Johnson & Johnson’s (NYSE:JNJ) orthopedic division DePuy, and California-based SI Bone.
The Eden Prairie, Minn.-based company has raised at least $9.75 million since 2008, according to SEC filings. Backers have included Split Rock Partners and Domain Associates. Expertise offered by Excelen, an orthopedics incubator, also helped Zyga get started. Before starting Zyga in 2008, CEO Robert Assell oversaw product development at TranS1, a North Carolina-based spine technology company.
Americans spend at least $50 billion annually on back pain, according to the National Institute of Neurological Disorders and Stroke. Spine fusion surgeries numbered 413,000 between 2002 and 2008, according to a recent Bloomberg report criticizing the process. The market for minimally invasive sacroiliac joint surgery appears to be in its infancy, according to a review of the medical literature. Open surgery on the sacrum, previously the only option, is rarely done, according to the Mayo Clinic.
The market for SI surgery will likely rely in part on patients with previous spinal fusion of the lumbar. In a study cited on SI Bone’s web site, the incidence of SI joint degeneration in post-lumbar fusion patients was 75 percent.
A Zyga spokesperson did not immediately return a call for comment.