Synergy Biomedical Gains FDA Clearance of BIOSPHERE FLEX Graft

By Julie A. Vetalice

Synergy Biomedical received FDA 510(k) clearance to market BIOSPHERE® FLEX bone graft. Launch is slated for 4Q18.

The strip format product comprises porous, bioactive glass integrated within a collagen and sodium hyaluronate scaffold. The BIOSPHERE line also includes putty and a delivery system specifically designed for minimally invasive procedures; the MIS version launched earlier this month.

BioSphere technology is based on a spherical form of bioactive glass designed to support control over osseous healing. The FLEX format is reported to have one of the highest bioactive glass contents on the market due to higher granule density vs. other porous bone graft sheets.

Sources: Synergy Biomedical, LLC; ORTHOWORLD Inc.

Product Labels: Bone Graft Materials/DBM

Tags: 510(k) Clearance, Regulatory