FRANKLIN LAKES, N.J., Jan. 27 /PRNewswire/ -- Collagen Matrix, Inc. is pleased to announce that it has received FDA’s 510(k) clearance of its Collagen-Mineral Composite Bone Graft Material intended for use in orthopedic-spine applications involving bone repair. The Collagen-Mineral Composite Bone Graft Material, combined with autologous bone marrow, is used to fill bony voids or gaps of the skeletal system, including spine, extremities and pelvis.
The Collagen-Mineral Composite Bone Graft Material is a composite matrix available in strips, pads, or granular form for surgical implantation. The principle components of the product are type I collagen and anorganic bone mineral. The natural anorganic bone mineral is derived from bovine cancellous and cortical bone. Due to its natural structure, the Collagen-Mineral Composite Bone Graft Material is physically and chemically comparable to the mineralized matrix of human bone. The mineral particles are dispersed within highly purified type I collagen fibers forming a three-dimensional open porous matrix for use as an osteoconductive material. The addition of autologous bone marrow further enhances the bone forming capability of the product from bone inductive factors and bone forming cells in the bone marrow. The Collagen-Mineral Composite is provided as a sterile, dry material that is hydrated with autologous bone marrow at the point of use. The Collagen-Mineral Composite strips and pads can be cut into shapes and are designed to retain their shape and physical integrity following implantation into a bony site, while the granular form can be molded to fit the bone defect. The product is fully resorbed during the natural process of bone formation and remodeling.
“We continue to broaden our product portfolio in the orthopedic-spine market with the addition of the Collagen-Mineral Composite Bone Graft Material. This 510(k) clearance comes on the heels of our recent FDA clearance of the Collagen Bone Healing Protective Sheet for use in bone repair, which is an excellent companion product to the Collagen-Mineral Composite. We expect these products to make a solid contribution to our Company’s growth this year,” said Shu-Tung Li, Ph.D., Founder and CEO, Collagen Matrix.
Collagen Matrix, Inc. is a leader in the design and engineer of collagen-based extra-cellular matrices for tissue and organ repair and regeneration. The Company currently manufactures collagen-based finished medical devices in areas of oral surgery, neurosurgery, orthopedic surgery, and wound care. For more information, see http://www.collagenmatrix.com.
Contact: Shu-Tung Li, Ph.D., (201) 405-1477
Collagen Matrix, Inc.
CONTACT: Shu-Tung Li, Ph.D., +1-201-405-1477
Web site: http://www.collagenmatrix.com/
