Medtronic Gains Expanded Indication for Bone Cement

The FDA granted expanded 510(k) clearance for Medtronic’s Kyphon HV-R bone cement, designed to fixate pathological fractures of the sacral vertebral body.

The bone cement already has an indication for fixing pathological fractures of the sacral vertebral body or ala using sacroplasty or sacral vertebroplasty.

The bone cement’s expanded indication now allows it to treat fractures caused by osteoporosis, cancer or benign lesions by using a cementoplasty procedure.