FDA Clears ZygoFix Spinal Fusion Alternative

FDA has cleared a ZygoFix 510(k) for its zLOCK Lumbar Facet Fixation System. ZygoFix’s device “harnesses the spine’s innate bone structure to securely lock its connecting joints,” the company says. “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 environments,” it says.

The device is described as a miniature implant that provides stability to achieve spinal fusion. It is inserted inside the joint and anchors into both bones to immobilize motion, ZygoFix says. It is made from titanium, and adjusts its shape during implantation to accommodate the synovial joint anatomy. “With zLOCK, the surgeon utilizes the natural construction of the vertebrae to provide spinal stability, and thereby eliminate the need to insert pedicle screws,” it adds.