FDA OKs Ventris Medical’s Backpack Bone Graft Containment System

Ventris Medical, an orthobiologics and tissue regeneration company, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Backpack (Porous Biologic Scaffold, K240765).

Backpack represents a new class of biomaterials designed to optimize cell proliferation and bone formation for orthopedic and spinal procedures. It comes in two versions. One is a collagen mesh pouch prefilled with the company’s osteoinductive Allocell AF fibers, and the second is prefilled with its surface activated Amplify granules.

Backpack AF prefilled with Allocell AF allograft fibers

In this format, the osteoinductive allograft fibers are enclosed inside a collagen mesh pouch. The biologic graft system is the first, according to Ventris, in that both the containment pouch and allograft fibers contribute to bone remodeling at the graft site.

The Allocell AF fill has a scaffold-like structure and its osteoinductive nature promotes differentiation of stem cells into bone-forming cells. Backpack AF is supplied in a ported pouch for easy hydration.

Backpack AMP prefilled with surface activated Amplify granules

In this configuration, surface-treated, biphasic Amplify granules are enclosed in 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 healing stages and supports progressive bone remodeling throughout the fusion process.

Ventris’ Amplify synthetic bone graft putty received FDA 510(k) clearance in March 2024.

Russell Cook, CEO of Ventris Medical said, “We are very pleased to receive FDA clearance for both the Backpack AF and Backpack AMP Bone Graft Systems. This graft containment technology is the first of its kind and represents a huge step forward in the bone graft technology available in today’s market. Backpack combines 2 heavily studied components; osteoinductive allograft fibers and our patented surface activated biphasic mineral components and places them in a biologic containment system providing an anti-migration feature not found in any other bone graft offering. Our company mission is to continue to develop next generational devices that bring excitement to the surgeon community as well as our distribution partners.”