The Israel-based company said the milestone was supported by clinical evidence from its ongoing European clinical study, marking a significant advancement for its spinal fusion technology.
“Receiving FDA clearance for our zLOCK Lumbar Stabilization System is an exciting milestone, and I am very proud of the team that has worked hard to achieve this goal. The system has garnered significant interest in the U.S. market and this clearance paves the way for us to introduce our transformative solution to the U.S. market, fostering collaboration with leading surgeons and enhancing patient care,” CEO Ofer Levy said in a news release.
Spinal fusion is a common surgical procedure that is performed for degenerative spinal conditions, such as spondylolisthesis, spinal stenosis and degenerative disc disease. The gold-standard treatment involves placing four screws and two rods to create an artificial bridge to stabilize the segment. However, the conventional invasive approach requires precise placement and building of bridges intraoperatively.
“Obtaining 510(k) clearance is a testament to ZygoFix’s commitment to innovation and addressing the unmet needs of patients suffering from degenerative spinal conditions. We eagerly anticipate offering patients our minimally invasive, life-changing solution in the United States,” ZygoFix Chair Nicholas Pachuda said.
ZygoFix designed its ZLock system to use the spine’s innate bone structure to lock its connecting joints securely. Unlike some traditional methods, the company’s implant adapts to the joint’s anatomy during insertion, according to the company. The zLock system gives surgeons stability with a minimally invasive procedure that can be performed in outpatient and ASC environments.
“The simplicity and minimally invasive nature of the zLOCK system provides a new tool in the surgeon’s offering. For the right patients, zLOCK can provide a great alternative to pedicle screws,” said Dr. Isador Lieberman, Orthopedic and Spine Surgeon at Texas Back Institute.
