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Orthopaedic Industry News & Orthopaedic Company News | Orthogate Professionals

Details
By Editor-in-Chief
Editor-in-Chief
Industry News
10 March 2016

FDA Ortho Panel to Vote on Cartiva Synthetic Cartilage Implant

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.

Visit Original Source

Last Updated: 12 March 2016
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