Bioventus—a global provider in innovations for active healing—announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s neXus BoneScalpel Access handpiece.
The BoneScalpel Access handpiece is powered by the neXus Ultrasonic Surgical Aspirator System, an integrated ultrasonic surgical platform driven by a proprietary digital algorithm. The neXus system combines all the features of soft and hard (e.g. bone) tissue removal into a single fully integrated offering.
“The BoneScalpel Access handpiece provides surgeons with a new option for confined spaces during minimally invasive surgery, enabling safe and powerful bone removal with maximum visualization. In addition, BoneScalpel Access allows for en-bloc resection and the shaving and sculpting of bone, with built-in irrigation and aspiration with improved ergonomics for the end user,” says Sharon Klugewicz, senior vice president, Quality and Regulatory Affairs, Bioventus.
Bioventus plans to launch BoneScalpel Access in 2022. The neXus Ultrasonic Surgical Aspirator System has been commercialized successfully in the U.S., Canada, Europe, and Australia.