Centinel Spine wins FDA 510(k) for Altos cervical spine implant

Centinel Spine said today it won FDA 510(k) clearance for its Altos posterior cervical thoracic stabilization system with indications for use in lateral masses of the cervical spine or pedicles of the cervical-thoracic spine.

The West Chester, Penn.-based company said the 1st surgical implantation of the system was performed earlier this month at Las Vegas’ Western Regional Center for Brain & Spine Surgery.

“Altos is a comprehensive system that was designed to provide the surgical versatility needed to address posterior cervical spinal pathologies. The low profile system is simple to insert minimizing patient trauma and surgical time. It can also be easily customized to successfully address many patients’ degenerative pathologies,” Dr. Jason Garber of the Western Regional Center for Brain & Spine Surgery said in prepared remarks.

Centinel Spine said the Altos is the 1st FDA cleared posterior cervical thoracic system designed for its indications, and its low profile stabilization system offers fully threaded, smooth shank polyaxial screws with 80 degrees of freedom.

“Centinel Spine is dedicated to developing products that address surgical needs, anatomical challenges and surgeon requirements. We look forward to seeing the successful clinical outcomes and evidence that Altos was designed to achieve. We are proud to deliver the Altos system, Ti-Active technology and Stalif product families to patients around the world. The Altos system exemplifies our commitment to advancing the standard of care in spinal fusion procedures with our clinically proven technologies,” CEO John Viscogliosi said in a press release.

The company said the system also comes with laminar hooks, connectors, straight and curved rods for customized constructs to meet each patient’s needs independently.

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