K2M Releases New Spine Putty

Leesburg, Va.-based K2M Inc., a spine device company focused on complex spinal pathologies and minimally invasive procedures, has expanded its U.S. biologics offering with the new Vesuvius DBM (demineralized bone matrix) putty. The product is part of the Vesuvius osteobiologic systems line.

DBM is a manufactured product that includes pieces of cortical bone that are demineralized (the removal of calcium and phosphate) to expose the osteoinductive proteins contained in the matrix.

Like the Vesuvius demineralized fibers and Vesuvius demineralized sponge, the putty is processed by Lifenet Health, an allograft bio-implant and regenerative medicine company based in Virginia Beach, Va. There, the products are treated with Lifenet’s Allowash XG sterilization process and PAD demineralization technology to protect bone morphogenic proteins (molecules involved in the growth and maintenance of bone and soft tissues), while ensuring optimal osteoinductive potential. The new putty incorporates proprietary bone-fiber technology and a glycerol carrier to provide an enlarged surface area to facilitate attachment, migration, and distribution of cells within the graft material, K2M claims.

“K2M’s launch of Vesuvius DBM Putty is an important expansion of their biologics portfolio,” said Paul Savas, M.D., K2M’s medical director for tissue products and orthopedic surgeon in Williamsburg, Va. “DBM putty is a commonly used osteobiologics solution for spinal fusions, and this offering incorporates a unique carrier for handling characteristics, while incorporating Lifenet’s PAD process to achieve the ideal residual calcium necessary for optimal osteoinductive potential. Products can be designated as demineralized if the residual calcium level is less than 8 percent. However, studies show that residual calcium in the range of 1 to 4 percent provides the most osteoinductive potential. This is the range that the PAD process targets consistently.”

President and CEO of K2M, Eric Major, said that the launch of the Vesuvius DBM putty is part of K2M’s larger effort to strengthen its presence in the biologics market.