The Aranax Cervical Plate from Xtant Medical unit X-spine Systems has obtained clearance from the FDA. The product, indicated for patients requiring spinal fusion on one to four adjoining cervical spine levels, is set for a limited release next quarter and a full launch early next year.
Licensing and distribution deals were struck between Intellirod Spine and X-spine Systems to give Intellirod the right to use X-spine's Fortex implants with its LOADPRO disposable microelectronic sensor. The system helps surgeons track the levels of rod strain during corrective spinal surgeries.
The FDA has cleared X-Spine to market its Zygafix Facet Fusion System, which is implanted using a minimally invasive procedure to help stabilize the facet joint. The system adds to the company's Silex and Axle lines of novel spinal-fusion devices.
X-Spine has secured FDA clearance for its AXLE-PEEK device, which is designed to treat patients with degenerative disk disease. The device, which the company says can be delivered via a smaller incision than traditional systems, gives spine surgeons the choice between a titanium or polymer implant material.