FDA 510(k) Clearance for Prosidyan FIBERGRAFT BG Putty

By Julie A. Vetalice

Prosidyan received FDA 510(k) clearance of FIBERGRAFT BG Putty for use in posterolateral spinal fusion.

The product comprises FIBERGRAFT Morsels delivered via the OssiGlide® proprietary bioactive carrier. Each granule of BG Morsels contains a porous outer shell surrounding a nest of fibers and bioactive glass microspheres, which are intended to offer an ample surface area for cell growth. Further, the differing sizes within each morsel resorb at different rates, creating a supportive environment throughout the phases of bone healing.

To date, FIBERGRAFT products have been implanted in >7,000 patients across the U.S.

Sources: Prosidyan, Inc.; ORTHOWORLD Inc.

Product Labels: Bone Graft Materials/DBM

Tags: 510(k) Clearance, Regulatory