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 conditio…