Spinal implants and surgical instrument developer X-spine touted 2 FDA nods for its new spinal systems, which the company plans to include in a launching spree that will take place over the next year.
The next-generation Fortex CoCr system, which features a new cobalt-chromium fixation rod, is designed for the fixation of the thoracic and lumbar spine, particularly in deformity procedures.
The newly cleared Certex system expands the company’s product portfolio into posterior cervical spine, providing implants and an instruments platform for cervical stabilization procedures.
"Both the Fortex CoCr and the Certex were developed with intensive practitioner input to address the practical needs of spine surgeons and patients worldwide," president & CEO Dr. David Kirschman said in prepared remarks.
The Miamisburg, Ohio-based company intends to roll out the devices alongside 3 others over the next year, Kirschman added.
"It is our strategy to be able to address every instrumented spinal pathology and approach with our products, while leading with innovative design and surgical practicality,” he said. “These 2 clearances exemplify this strategy, and represent the beginning of a new product initiative at X-spine which will see 5 major product introductions in the next year.”