Collagen Matrix, a leader in regenerative medicine and a global manufacturer of collagen and mineral based medical devices announced today the FDA 510(k) clearance of its innovative line of Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix through its Spine business unit.


Image: Collagen Matrix received FDA 510(k) clearance for Bioactive Moldable Bone Graft Matrix. Photo: Courtesy of Dr. Manuel González Reyes from Pixabay.

OssiMend Bioactive Moldable Bone Graft Matrix is a perfect trio of anorganic carbonate apatite bone mineral, 45S5 bioactive glass and highly purified Type I collagen that can be molded into putty for filling irregular defect sites. The matrix is an osteoconductive, bioactive, porous implant that allows for bony ingrowth across the graft site. OssiMend® Bioactive Moldable is slowly resorbed and replaced by new bone tissue during the natural healing process. The matrix is available in various sizes including a unique 25cm long, 40cc strip for complex spine fusion surgeries. OssiMend® Bioactive Moldable joins the Company’s wide range of implantable collagen and mineral based medical devices.

“We continue to expand our product portfolio for the Spine market with the development of this unique line of Bioactive bone graft matrices that combines a carefully-selected ratio of three powerful components. This innovative moldable version offers surgeons options for better ensuring predictable outcomes,” said Bart J. Doedens, CEO of Collagen Matrix, Inc.

Source: Company Press Release.