G21 today said its SpaceFlex Shoulder modular spacer received FDA 510(k) clearance.
SpaceFlex is designed for the treatment of periprosthetic infection to allow for the creation of a modular spacer with G21 antibiotic-loaded bone cement for arthroplasty revision in the operating room. It is ready to use in 15 minutes and surgeons can device on sizes during surgery based on a patient’s anatomy.
The shoulder spacer implant creates an antibiotic-loaded bone cement shoulder spacer to allow surgeons to decide on stem and head diameters and head offset. It comes in stem diameter sizes of 8, 10, 12, 14 mm; head diameters of 42 and 48 mm and head offset of 15 and 18 mm.
“The achievement of this result for G21 means being able to offer a dedicated treatment of each infected joint,” executive VP Filippo Foroni said in a news release. “Since we set up the company in 2009, we are committed to providing our patients with better health conditions. The addition of SpaceFlex Shoulder to our product portfolio represents a user-friendly solution for complex issues.”