US-based medical device company Synergy Biomedical's bone graft Biosphere Putty has secured CE mark clearance in the European Union (EU).
Biosphere Putty is a synthetic bone graft that uses a combination of bioactive glass with a moldable phospholipid carrier.
The clearance allows the use of Biosphere Putty as a bone graft material for filling bony voids or gaps of the skeletal system, for interbody and posterolateral fusion, as well as general bone defect filling in the extremities and pelvis.
The bone graft can be used alone or in combination with autograft or allograft.
Synergy Biomedical president and chief executive officer Dr Mark Borden said: “Since its introduction, Biosphere Putty has been very well received by surgeons due to its successful clinical use and excellent intraoperative handling.
“We are very pleased to receive our CE mark and are looking forward to introducing a truly next generation, synthetic bone graft product to the European community.”
Initially launched in the US in 2013, the bone graft is equipped with the company's patented BioSphere technology.
It was found in vivo that Biosphere Putty's spherical particle shape and optimised, bimodal size range can improve the healing potential of bioactive glass.
The bone graft is said to apply an advanced understanding of bioactive glass to induce a cellular level response and to offer a suitable physical environment for even and predictable bone ingrowth.
It is claimed to be easy to use and compatible with different bone grafting techniques.