SOUTHBURY, Conn., Nov. 17 /PRNewswire/ -- Doctors Research Group, Inc. announced today that it has received 510(k) approval from the U.S. Food and Drug Administration (FDA) to market KRYPTONITE(TM) Bone Cement for cranioplasty applications.
On sale for several years in Europe, and more recently in Canada, Latin America and Australia, KRYPTONITE(TM) Bone Cement is a self-setting bone cement formed by combining three naturally occurring components to create an adhesive, low exotherm, non-toxic bone repair solution that cures with porous properties and is engineered to mimic natural bone. KRYPTONITE(TM) Bone Cement polymerizes in stages, offering surgeons the option to inject it as a liquid, to secure bone-to-bone adhesion, or to shape it as a moldable putty, to create form fitting plates which eliminate the need for painful bone grafts that prolong patient recovery times.
Doctors Research Group intends to begin marketing KRYPTONITE(TM) Bone Cement to U.S. surgeons and hospitals immediately.
To find out more, please visit www.KryptoniteUSA.com.
Doctors Research Group, Inc.
