FDA Expands Clearance Of BioSphere Putty For Spine Indications
COLLEGEVILLE, Pa.--(BUSINESS WIRE)--Synergy Biomedical, LLC, a developer of novel biomaterial products, has announced that it has received 510(k) clearance from the US Food and Drug Administration to market BioSphere Putty as a bone graft extender for use in the posterolateral spine.
“We are very pleased to receive the expanded spine indication for BioSphere Putty,” stated Dr. Mark Borden, Ph.D., President/CEO of Synergy. “The expanded clearance will give spine surgeons access to a next generation bioactive bone graft product that can be used in challenging spine fusion surgery. The clearance will also allow us to greatly expand our growing distribution network, and get the product into more surgeon’s hands.”
Under its expanded indications, BioSphere Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. BioSphere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis, and as a bone graft extender in the posterolateral spine. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
BioSphere Putty is Synergy’s first bone graft product utilizing patented bioactive glass spheres that have been shown to improve the bone healing properties of bioactive glass. The product provides surgeons with a moldable bone graft material that has the highest bioactive glass content on the market.