Biogennix Gains Additional FDA Clearance for Agilon Moldable Bone Graft

By Julie A. Vetalice

Biogennix Gains Additional FDA Clearance for Agilon Moldable Bone Graft

Biogennix received FDA 510(k) clearance for an expanded indication for its Agilon™ moldable bone graft for use in posterolateral spine procedures when mixed with autograft. The product was granted initial clearance last year for use in bony voids or gaps that are not intrinsic to the stability of the bony structure.

Agilon addresses surgeon demand for a collagen-enhanced product, complementing the company’s existing Morpheus™ and osteoSPAN™ products. It features TrelCor™ material that is engineered to mimic human cancellous bone. Interconnected pores average 500 microns (µ) in size, and all surfaces throughout the porosity are covered by 4 microns of calcium phosphate. Studies indicate that TrelCor allows Biogennix's bone graft material to become incorporated into a bone fusion while gradually resorbing over a 6-12 month period.

Agilon requires no hydration prior to use and represents the only collagen-enhanced synthetic bone graft to be packaged in an open-barrel syringe.

“Receiving the spine indication for Agilon is exciting news and enables us to make the product available to spine surgeons throughout the U.S.,” said Biogennix Vice President of Sales and Business Development, Scott Bauccio. “Based on the enthusiastic feedback we’ve received from surgeons and distributors since the product launched last year, we anticipate Agilon to be a significant addition to our product offering for spine procedures.”

Product Labels: Synthetic Bone Graft

Tags: ["510(k) Clearance","Regulatory"]