BONESUPPORT announced FDA 510(k) clearance allowing the use of CERAMENT G in open fractures.
CERAMENT G is an orthopedic medical device combination matrix consisting of a resorbable synthetic bone graft substitute and the antibiotic gentamicin, which protects against colonization of bacteria sensitive to gentamicin.
The clearance more than doubles the U.S. addressable market for CERAMENT G, which is reported to be the first and only combination product cleared in the USA for this indication.
“Open fractures are one of the most common causes of a patient developing a bone infection, and we are very excited about this expanded indication. It means that American surgeons will have a new powerful tool to treat patients with skeletal injuries while simultaneously protecting the site from infection by local elution of antibiotics,” said Emil Billbäck, CEO of BONESUPPORT.
BONESUPPORT announced FDA 510(k) clearance allowing the use of CERAMENT G in open fractures.
CERAMENT G is an orthopedic medical device combination matrix consisting of a resorbable synthetic bone graft substitute and the antibiotic gentamicin, which protects against colonization of bacteria sensitive to gentamicin.
The clearance more than...
BONESUPPORT announced FDA 510(k) clearance allowing the use of CERAMENT G in open fractures.
CERAMENT G is an orthopedic medical device combination matrix consisting of a resorbable synthetic bone graft substitute and the antibiotic gentamicin, which protects against colonization of bacteria sensitive to gentamicin.
The clearance more than doubles the U.S. addressable market for CERAMENT G, which is reported to be the first and only combination product cleared in the USA for this indication.
“Open fractures are one of the most common causes of a patient developing a bone infection, and we are very excited about this expanded indication. It means that American surgeons will have a new powerful tool to treat patients with skeletal injuries while simultaneously protecting the site from infection by local elution of antibiotics,” said Emil Billbäck, CEO of BONESUPPORT.
Copy to clipboard 
