FDA Panel Backs Cartiva Synthetic Cartilage Implant

FDA’s Orthopedic and Rehabilitation Devices Panel has voted 10 to 2 to recommend approval for a Cartiva PMA for its synthetic cartilage implant for treating degenerative and post-traumatic arthritis in the first metatarsophalangeal joint. The panel based its decision on data from the company’s MOTION study, which showed that those receiving the implant experienced a high success rate while undergoing a shorter surgery, maintained motion in the metatarsophalangeal joint and avoided risks of nonunion and hardware fracture compared with patients who underwent fusion. Panel members also recommended that, if approved, a post-approval study be conducted to determine any safety issues. occur. Additionally, they noted there should be strict limitations on the indications for use, which would exclude patients with hallux valgus or an “unstable joint.”