Ventris Medical, a privately held orthobiologics and tissue regeneration company, announced that the United States Food and Drug Administration has granted 510(k) clearance for Backpack® (Porous Biologic Scaffold, K250556) for use in the Intervertebral Disc Space. Backpack® represents a new class of biomaterials designed for the optimization of cell proliferation and bone formation and is used in orthopedic and spinal fusion procedures. Backpack® is available in 2 versions. One version consists of a collagen mesh pouch filled with our osteoinductive Allocell® AF fibers and in the second version, the collagen mesh pouch is filled with our surface activated Amplify® granules.

In this format, the osteoinductive allograft fibers are completely enclosed inside a collagen mesh pouch. The 100% biologic graft system is the first of its kind in that both the containment pouch and allograft fibers contribute to the bone remodeling process at the graft site. The Allocell® AF allograft fill has a scaffold-like structure, enabling bone cells to attach and proliferate, which helps facilitate the natural healing process. The osteoinductive nature of the Allocell® AF fibers actively promote the differentiation of stem cells into bone-forming cells, which enhances bone regeneration. Backpack® AF is supplied in a ported pouch for easy hydration and is ready to use, simplifying the surgical process.