Bioventus Gains FDA Clearance for BoneScalpel Access

By Julie A. Vetalice

Bioventus Gains FDA Clearance for BoneScalpel Access

Bioventus received FDA 510(k) clearance to market the neXus® BoneScalpel® Access™ handpiece. The BoneScalpel Access handpiece is powered by the neXus Ultrasonic Surgical Aspirator System, a next-generation integrated ultrasonic surgical platform driven by a proprietary digital algorithm resulting in more power, versatility and control. The neXus system combines all the features of soft and hard (e.g. bone) tissue removal into a single fully integrated offering.

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.

“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,” said Sharon Klugewicz, Senior Vice President, Quality and Regulatory Affairs, Bioventus.

Source: Bioventus

Tags: 510(k) Clearance, Regulatory