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FDA 510(k) Clearance for Kyphon Xpede Bone Cement


Medtronic received FDA 510(k) clearance of Kyphon™ Xpede Bone Cement for fixation of pathological fractures of the sacral vertebral body, or ala, using sacroplasty. This is an expansion of previous indications for treatment of vertebral fractures due to osteoporosis, cancer or benign lesions.

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%.

Stryker's VertaPlex® HV was reportedly the first polymethylmethacrylate bone cement to receive FDA 510(k) clearance for the fixation of pathological fractures of the sacral ala using sacroplasty, as announced in 4Q15. (The clearance occurred in 2Q15.)

Sources: Medtronic plc; ORTHOWORLD Inc.