Ventris Medical Receives 510(k) Clearance for Innovative Backpack® Bone Graft Containment System

NEWPORT BEACH, Calif., Jan. 9, 2025 /PRNewswire/ -- Ventris Medical, a privately held orthobiologics and tissue regeneration company, today announced that the United States Food and Drug Administration has granted 510(k) clearance for Backpack® (Porous Biologic Scaffold, K240765)). 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 prefilled with our osteoinductive Allocell® AF fibers and in the second version, the collagen mesh pouch is prefilled with our surface activated Amplify® granules.

Backpack® AF Prefilled with Allocell® AF Allograft Fibers

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.

Backpack® AMP Prefilled with Surface Activated Amplify® Granules

In this format, the surface treated biphasic Amplify® granules are completely enclosed inside the collagen mesh pouch. The hybrid mixture of surface-activated biphasic granules are composed of two distinct HA-to-βTCP blends that resorb at different rates. These surface-activated granules are derived from conventional HA/BTCP granules with ratios of 20/80 (faster resorbing) and 60/40 (moderate resorption), resulting in a bimodal dissolution profile that nourishes the fusion site in the early stages of healing and supports progressive bone remodeling throughout the fusion process. Backpack® AMP is supplied in a ported pouch for easy hydration and is ready to use, simplifying the surgical process.

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