Integra has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Cusa NXT bone tips, which are used with the company’s existing Cusa NXT ultrasonic tissue ablation system. The NXT system is used primarily in neurosurgical procedures for the removal of soft tissue and bone near critical structures, and the bone tips are intended to expand the surgical applications of the Cusa NXT system.
By removing the need for drills and other similar tools, the bone tips are expected to allow surgeons to use ultrasonic tissue ablation in procedures requiring precise, controlled bone removal near locations in the body where the rotational motion of a drill or frictional heat may be a concern. They feature a one-piece tip design, low profile silicone flue, and an ergonomic shroud that are all disposable.
According to Integra, the Cusa NXT system is used in more than 2,000 centers worldwide.
Based in Plainsboro, N.J., Integra Lifesciences develops medical devices for orthopedics, neurosurgery, spine, reconstruction, and general surgery.