The Fortex and the Xpress 2 Pedicle Screw System, developed by Xtant Medical unit X-spine Systems, have been cleared by the FDA for additional indications. The clearance covers the extended-length screws as well as the products' use in ilium fixation. The screws were developed to complement fusion in addressing spinal tumors, kyphosis, scoliosis, dislocation, fracture, previously unsuccessful fusion and degenerative spondylolisthesis.
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 been cleared by the FDA to market its Silex system for sacroiliac joint fusion. The device, which is being showcased at an orthopedic meeting this week in Chicago, is implanted using less-invasive incisions and is designed to stabilize the SI joint even in patients who have received failed treatments.
Miamisburg, Ohio-based X-Spine Systems has secured clearance from the FDA for its Calix PC spinal implant device. The device, which employs plasma coating technology, offered better resistance to expulsion than noncoated implants during laboratory tests.