Collagen Matrix announced that the U.S. Food and Drug Administration (FDA) has cleared its SynOss synthetic material, a type of artificial bone, for oral surgery.
The company said it had received 510(k) clearance for the bone substitute, meaning the FDA deems it at least as safe and effective as materials previously approved for the same purpose.
SynOss synthetic mineral is an osteoconductive calcium phosphate-based bone graft material. Unlike hydroxyapatite materials, SynOss' has a carbonate apatite structure, which is more comparable to the mineralized matrix structure of human bone.
That's a key feature, the manufacturer claims, because the similarity in structure between SynOss and natural bone mineral allows for SynOss' in vivo resorption and remodeling profile to mimic that of natural bone.
The product adds to Collagen Matrix's line of synthetic tissues and dressings for dental and oral surgery, including DuraMatrix for dural repair, Neuroflex, and NeuroMatrix for peripheral nerve repair, OssiMend for bone repair in orthopedics and spine, and the Matrix Collagen Family of Products for wound care.
"Our goal is to provide the dental and oral surgical markets with a full line of innovative products for use in regenerative medicine," said Shu-Tung Li, PhD, founder and CEO of Collagen Matrix. "The addition of SynOss is another step in reaching that goal."
