EXACTECH RECEIVES FDA CLEARANCE FOR POLYETHYLENE HIP ACETABULAR LINER
Exactech, a developer and producer of bone and joint restoration products including orthopedic implants and biologic materials, has received 510(k) clearance from the FDA for its Connexion GXL enhanced polyethylene acetabular liners for its AcuMatch A-Series system.
Connexion GXL polyethylene is processed with an elevated level of irradiation, which testing has demonstrated significantly reduces polyethylene wear while maintaining an appropriate level of fracture toughness.
The new product complements the press fit femoral stems that Exactech launched earlier this year as the first element of its Novation Comprehensive Hip System. The combination of enhanced polyethylene and press fit stems addresses more than 50 percent of the total hip market the firm estimated.