Anika Announces FDA 510(k) Clearance for its WristMotion® Total Arthroplasty System for the Replacement of Painful Wrist Joints

Anika Therapeutics announced that the Company’s WristMotion Total Arthroplasty System received 510(k) clearance from the U.S. Food and Drug Administration. The WristMotion Total Arthroplasty System is indicated for replacement of the painful wrist joint due to rheumatoid arthritis, osteoarthritis, or post-traumatic arthritis.

Cheryl R. Blanchard, Ph.D., President and Chief Executive Officer of Anika Said: “We are delighted to receive clearance for this innovative wrist device as it is another step forward in our mission to provide motion preserving technologies. This is an underserved market and our solution is in response to demand from both orthopedic surgeons and patients for solutions that avoid fusion and preserve as much natural motion and anatomy as possible, For Anika, this is another new product category coming from our recently acquired Arthrosurface business, which has a storied history of introducing orthopedic innovations that are minimally invasive, bone-sparing, and motion preserving. All too often, painful wrists caused by arthritis or trauma are treated by fusing the joint. We want to provide alternatives to that outcome that preserve joint motion for the patient. While fusions alleviate pain, the loss of motion in a wrist can be quite life changing, perhaps more than patients initially realize. Anika is committed to doing all that we can to allow patients to remain active and truly live life to the fullest.”

The WristMotion Total Arthroplasty System is a modular joint restoration system that replaces both the radial and carpal portions of the joint. The system is unique in that it combines the patented and proven fixation and dual curvature implant geometries with a unique instrumentation system that allows for precise implant placement and joint tensioning. A design philosophy for the system was to preserve the complex kinematics of the joint, often referred to as the ‘dart throwers’ motion.

Arnold-Peter C. Weiss, M.D., Chief - Hand, Upper Extremity & Microvascular Surgery, Vice Chairman and Professor of Orthopaedics, Warren Alpert Medical School, Brown University Said: “With new kinematic information on implant design and function, the anatomic WristMotion Total Arthroplasty System utilizes an innovative articulating design for greater range of motion in both flexion/extension and radial/ulnar deviation. The WristMotion platform also allows intraoperative decision making with regards to performing a hemi or total arthroplasty to treat all stages of wrist arthritis. The R&D team worked extremely hard to design this new solution for wrist arthritis and I’m thrilled to see this device come to market and benefit patients.” With over 30 years of clinical experience in total wrist arthroplasty, Dr. Weiss provided his expertise as the lead surgeon designer of the WristMotion Total Arthroplasty System.

The 510(k) clearance for the WristMotion system triggers a one-time $5 million earnout payment as a result of the achievement of a regulatory milestone set forth in the merger agreement executed among Anika and Arthrosurface, Incorporated on January 4, 2020. This earnout payment will be paid in the fourth quarter of 2020.

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