Biosphere Putty uses patented bioactive glass spheres that have been shown to improve the bone healing properties of bioactive glass.
With the new 510(k) approval, Biosphere Putty is indicated to be gently packed into bony voids or gaps of the skeletal system as bone void filler in the extremities and pelvis, and as bone graft extender in the posterolateral spine.
The bone graft product provides bone void filler that resorbs and is replaced with bone during the healing process.
Synergy Biomedical president and CEO Dr Mark Borden said: "We are very pleased to receive the expanded spine indication for BIOSPHERE PUTTY.
"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."