Synergy Biomedical received FDA 510(k) clearance and commenced full launch of BIOSPHERE® MIS PUTTY, comprising a pre-loaded bone graft cannula and trigger-based delivery system for open, mini-open and percutaneous minimally invasive procedures.
The system is available as a kit (with dispenser and putty-filled cannula) and in individual replacement cannulas to reload the delivery system.
BIOSPHERE bioactive glass-based bone graft putty has been marketed in the U.S. since 2013 and received CE Mark approval in 2017.
Sources: Synergy Biomedical, LLC; ORTHOWORLD Inc.