FDA OKs Ventris Medical’s Backpack Bone Graft in the Intervertebral Disc Space

Ventris Medical, an orthobiologics and tissue regeneration company, has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance for the Backpack porous biological scaffold for use in the intervertebral disc space.

Backpack is a new class of biomaterials for optimization of cell proliferation and bone formation, used in orthopedic and spinal fusion procedures. It’s available in two versions—one consisting of a collagen mesh pouch filled with the company’s osteoinductive Allocell AF fibers and a collagen mesh pouch filled with the company’s surface activated Amplify granules.

Backpack AF with Allocell

Here, the osteoinductive allograft fibers are enclosed in a collagen mesh pouch. The biologic graft system is a first of its kind, in that both the containment pouch and allograft fibers contribute to bone remodeling at the graft site.

The Allocell AF allograft fill has a scaffold-like structure so bone cells can attach and proliferate, helping facilitate the natural healing process. Allocell’s osteoinductive nature promotes differentiation of stem cells into bone-forming cells, enhancing bone regeneration. Backpack AF comes in a ported pouch for easy hydration.

Backpack AMP with Amplify

Here, surface-treated Amplify granules are enclosed in the collagen mesh pouch. The hybrid mixture of surface-activated biphasic granules are made of two HA-to-βTCP blends that resorb at different rates.

The granules are derived from conventional HA/BTCP granules with ratios of 20/80 (faster resorbing) and 60/40 (moderate resorption). This results in a bimodal dissolution profile that nourishes the fusion site at the early healing stages and supports progressive bone remodeling throughout fusion. Backpack AMP comes in a ported pouch for easy hydration.

“We are very pleased to receive FDA clearance for both the Backpack AF and Backpack AMP Bone Graft Systems,” said Ventris Medical CEO Russell Cook. “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.”

The company earned the initial FDA nod for the Backpack porous biologic scaffold in January 2025.