ZygoFix Ltd. a portfolio company of The Trendlines announced that it received regulatory clearance from the United States Food and Drug Administration (FDA clearance) for its zLOCK Lumbar Facet Fixation System.
This achievement was supported by compelling clinical evidence from the company’s ongoing European clinical study, marking a significant advancement in spinal fusion technology.
Spinal fusion, a common surgical procedure performed for degenerative spinal conditions such as Spondylolisthesis, Spinal Stenosis, and degenerative disc disease, traditionally requires placement of 4 screws and 2 rods, creating an artificial bridge, to stabilize the segment.
The conventional invasive approach requires precise placement and building of bridges intraoperatively. ZygoFix’s revolutionary zLOCK system harnesses the spine’s innate bone structure to securely lock its connecting joints. Unlike traditional methods, the company’s innovative implant adapts to the joint’s anatomy during insertion, offering unparalleled stability with a minimally invasive, simple procedure that can be performed in outpatient and ASC environments.
With CE certification and six years of clinical utilization yielding long-term pain reduction and bone growth, ZygoFix’s zLOCK Lumbar Facet Fixation System is positioned to revolutionize spinal fusion surgery.
ZygoFix CEO Ofer Levy remarked, “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 US market and this clearance paves the way for us to introduce our transformative solution to the US market, fostering collaboration with leading surgeons and enhancing patient care.”
Dr. Nicholas Pachuda, ZygoFix Chair, added: “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.”
Dr. Isador Lieberman, Orthopedic & Spine Surgeon at Texas Back Institute, commented: “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.”
