BONE SUPPORT RECEIVES “BREAKTHROUGH DEVICE DESIGNATION” FOR CERAMENT® V FOR THE INDICATION OF BONE INFECTION

Published: 2023-10-16

BONESUPPORT™, an emerging leader in orthobiologics for the management of bone injuries, today announces that the company's antibiotic eluting product CERAMENT® V has received categorization as a "breakthrough device" for the indication bone infection by the American Food and Drug Administration (FDA).

The categorization breakthrough device is assigned to products that are considered to provide a more effective treatment of severe medical conditions, where there is no comparable equivalent on the market. The categorization has been added to expedite the regulatory review of new medical devices and give patients faster access to new treatment options. CERAMENT® G has previously received breakthrough device designation for the indication's bone infection and trauma.