Medtronic’s Kyphon Cement Cleared for Sacral Fracture

By Julie A. Vetalice

Medtronic gained FDA 510(k) clearance to market Kyphon™ HV-R Bone Cement for fixation of fractures of the sacral vertebral body using sacroplasty. This expands on earlier indications for treatment of vertebral compression fractures caused by osteoporosis, cancer or benign lesions.

In 1Q17, the company received FDA 510(k) clearance of Kyphon™ Xpede Bone Cement for fixation of pathological fractures of the sacral vertebral body, using sacroplasty. Kyphon Xpede is a quick-to-dough bone cement that, when paired with the Kyphon Cement Delivery System, may minimize radiation exposure for clinicians by standing up to four feet away from the radiation source during injection, which has been measured to reduce hand radiation exposure by 70%.

Sources: Medtronic plc; ORTHOWORLD Inc.

Product Labels: Vertebroplasty/Kyphoplasty

Tags: 510(k) Clearance, Regulatory