FDA Panel to Convene on PMA for Cartiva’s Synthetic Cartilage Implant

By Julie A. Vetalice

On 4/20/16, FDA's Orthopaedic and Rehabilitation Devices Panel will meet regarding the PMA for Cartiva's Synthetic Cartilage Implant (SCI), an organic polymer-based biomaterial designed to mimic biologic cartilage.

SCI is to be indicated for treatment of degenerative and post-traumatic arthritis in the first metatarsophalangeal joint, in the presence of good bone stock and with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus and an unstable or painful metatarsophalangeal joint.

Source: GPO.gov


In 3Q15, Cartiva announced results from a Phase III randomized, controlled trial of SCI for the treatment of OA of the first metatarsophalangeal joint. Results indicated durable pain reduction and functional improvement similar to fusion, but with a statistically significant improvement in range of motion and a faster return to function.

Product Labels: Traditional Soft Tissue Repair

Tags: Premarket Approval