FDA ORTHO PANEL TO VOTE ON CARTIVA SYNTHETIC CARTILAGE IMPLANT (Orthopedics This Week)
Cartiva website
The FDA's Orthopaedic and Rehabilitation Devices Panel will meet on April 20, 2016 to discuss, make recommendations, and vote on the premarket approval application (PMA) for the Cartiva Synthetic Cartilage Implant (SCI), sponsored by Cartiva, Inc.
Cartiva's implant is an organic polymer-based biomaterial to mimic biologic cartilage. The device, according to an FDA announcement, is to be indicated for treatment of degenerative and post-traumatic arthritis in the first metatarsophalangeal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsophalangeal joint.
The FDA intends to make background material available to the public no later than two business days before the meeting.
The meeting will be held on Wednesday, April 20, 2016, from 8 a.m. to 6 p.m. at the Hilton Washington, DC/North, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, Maryland.
Last May we reported that the company submitted the final module for its PMA. The module covered the clinical results ...
