Bioventus receives FDA clearance of handheld bone scalpel
Bioventus Inc. has announced FDA 510(k) clearance of the neXus BoneScalpel Access handpiece, according to a press release.
The device is a handheld tool designed for resection, shaving, sculpting and removal of soft tissue and bone during minimally invasive surgery.
Bioventus plans to launch the neXus BoneScalpel Access handpiece in 2022, according to the release.
“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,” Sharon Klugewicz, senior vice president of quality and regulatory affairs at Bioventus, said in the release.
“The BoneScalpel Access handpiece represents the latest innovation in our best-in-class ultrasonic surgical platform, and we anticipate that surgeons will want to leverage our portfolio of bone graft substitutes to achieve bone fusion for their patients,” Klugewicz added.