Kuros Biosciences Receives Additional FDA 510(k) Clearance for MagnetOs Putty

By Julie A. Vetalice

Kuros Biosciences received FDA 510(k) clearance to market MagnetOs synthetic bone graft putty as an autograft extender in the posterolateral spine. Further, the company has filed for CE Mark approval in the EU.

MagnetOs was previously cleared in the U.S. in a granule format under its manufacturer, Xpand Biotechnology, which was acquired by Kuros in 1Q17. Per terms of that transaction, the putty clearance triggers a milestone issue of shares to the former owners of Xpand.

Sources: Kuros Biosciences AG; ORTHOWORLD Inc.

Product Labels: Synthetic Bone Graft

Tags: 510(k) Clearance, Regulatory