FDA Clearance for G21 SpaceFlex Shoulder

By Julie A. Vetalice

FDA Clearance for G21 SpaceFlex Shoulder

G21 was granted FDA 510(k) clearance to market the SpaceFlex Shoulder™, completing its Spaceflex line that includes hip and knee spacers.

"The achievement of this result for G21® S.r.l. means being able to offer a dedicated treatment of each infected joint," said Filippo Foroni, Executive Vice President. "Since we set up the company in 2009, we are committed to provide our patients with better health conditions. The addition of SpaceFlex Shoulder™ to our product portfolio represents a user-friendly solution for complex issues."

G21 provides bone cement for orthopedics with different levels of viscosity for the making of temporary prothesis for the treatment of infections and septic revisions. Earlier this year, the company completed its line of custom modular spacers with the introduction of the SpaceFlex r-evolution™ trials kit line to treat infection.

Product Labels: Elbow/Radial Head Replacement

Tags: 510(k) Clearance, Regulatory