Surgical device company Misonix has obtained clearance to market and sell its BoneScalpel, an ultrasonic osteotome system, in the People's Republic of China (PRC).
The State Food and Drug Administration (SFDA) of the PRC has granted registration certificate to the company for the commercialization of the bone cutting and compression device.
Designed for use in safe tissue selective bone dissection, the technology enables en bloc bone removal and refined osteotomies without involving elastic soft tissue structures.
According to the company, BoneScalpel is widely used for bone removal in the cervical, thoracic and lumbar spine, including for deformity cases across the globe.
Misonix president and chief executive officer Michael McManus said the company will now be selling the BoneScalpel in more than 48 countries outside the US.
"We believe the opportunity to sell the BoneScalpel in the People’s Republic of China and to work with prominent Chinese surgeons is an important step forward for our Company," McManus added.
Cicel, distributor of Misonix’s SonaStar neuro aspirator in China, has worked for the clearance of BoneScalpel in the region.
Cicel president May Lee said, "This state-of-the-art device provides surgeons with a much safer and more efficient approach when compared with existing technologies."