Synergy Biomedical Receives CE Mark for Biosphere Putty

By Julie A. Vetalice

Synergy Biomedical received approval under the CE Mark for BIOSPHERE synthetic bone graft putty for filling bony voids or gaps of the skeletal system, including application in interbody and posterolateral fusion and general bone defect filling in the extremities and pelvis. BIOSPHERE may be used alone or with autograft/allograft.

The bioactive glass + moldable phospholipid carrier received FDA 510(k) clearance and launched in 2013, and has been shown in vivo to significantly improve the healing potential of bioactive glass due to its spherical particle shape and optimized, bimodal size range whereby small particles resorb faster and generate ions more quickly than larger particles, which resorb more slowly and function as a longer-term scaffold for bone formation.

Sources: Synergy Biomedical, LLC; ORTHOWORLD Inc.

Product Labels: Synthetic Bone Graft

Tags: CE Mark, Regulatory