FDA Clears SeaSpine’s Demineralized Bone Matrix in Resorbable Mesh

SeaSpine Holdings Corporation, a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for use of its OsteoBallast Demineralized Bone Matrix (DBM) in Resorbable Mesh.
 
The OsteoBallast product is the latest innovation in SeaSpine’s orthobiologics portfolio that is designed to facilitate fusion. OsteoBallast, which consists of a resorbable mesh containing 100% DBM without a carrier, simplifies graft placement and helps prevent graft migration while maximizing DBM content. OsteoBallast is designed to provide surgeons with a simple means for delivering bone graft in posterior spine surgery that contours to the local anatomy while maintaining shape and volume under compression. The simplified technique is particularly valuable in MIS procedures, where placing the graft accurately through tubes and small incisions can be challenging.
 
“This product demonstrates SeaSpine’s continued commitment to innovation and our focus on delivering improved procedural spine solutions and clinical value through cost-effective orthobiologics,” commented Tyler Lipschultz, SeaSpine’s vice president of Orthobiologics and Business Development. “Coupled with the recent launch of our OsteoStrand Demineralized Bone Fibers product and our established Accell Bone Matrix (ABM) technology, SeaSpine now can offer surgeons additional options to address the varied needs of their patients.”
 
SeaSpine plans to launch the OsteoBallast product with a limited release by year-end and full commercial launch by mid-2018.