SeaSpine Gains FDA Clearance for OsteoBallast DBM in Resorbable Mesh

By Julie A. Vetalice

SeaSpine continues to broaden its orthobiologic offerings, receiving FDA 510(k) clearance to market OsteoBallast™ Demineralized Bone Matrix (DBM) in Resorbable Mesh. Limited launch will occur by year-end, with full commercial launch slated for mid-2018.

OsteoBallast comprises 100% DBM with no carrier, and is designed to deliver bone graft in posterior spine surgery. The product joins other biologic offerings such as OsteoStrand™ Demineralized Bone Fibers and the well-established Accell Bone Matrix. RAPID Graft Delivery, alpha-launched in 2Q17, is slated for full commercial launch in January 2018, with improvements based on feedback.

Sources: SeaSpine; ORTHOWORLD Inc.

Product Labels: Bone Graft Materials/DBM

Tags: 510(k) Clearance, Regulatory