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ZygoFix Receives FDA Clearance for its zLOCK Lumbar Facet Fixation System

MISGAV, Israel, May 6, 2024 /PRNewswire/ -- ZygoFix Ltd. a portfolio company of The Trendlines Group Ltd. ("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.

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