FDA Clears Anika Therapeutics Wrist Replacement System

The FDA has granted 510(k) marketing clearance to Anika Therapeutics, Inc. for the company’s new WristMotion Total Arthroplasty System.

Wait! What? The company that has been offering proprietary hyaluronic acid (HA) technology and regenerative therapies through Monovisc and Orthovisc since 1992, is coming out with a wrist replacement?

Anika Therapeutics Transformation

You read it right. Turns out the company has been quietly transforming itself into a joint preservation company focusing on early intervention orthopedic care. It has done so with the leadership of new CEO Cheryl Blanchard, Ph.D. and acquisition of orthopedic company, Arthrosurface, Inc. and Parcus Medical, LLC, a sports medicine company. WristMotion came to Anika from the Arthrosurface acquisition and follows Arthrosurface’s clinical and commercial success with the previously cleared motion preserving, HemiCAP Wrist.

Blanchard knows about medical devices, having been chief science officer, among other senior positions, for Zimmer Holdings.

WristMotion System

The system, according to an October 21, 2020 press release, is indicated for replacement of painful wrist joints due to rheumatoid arthritis, osteoarthritis, or post-traumatic arthritis.

According to the FDA clearance documents, the system is a modular joint restoration system “consisting of both a radial implant assembly and carpal implant assembly. The radial implant assembly is comprised of a metallic stemmed tray component and Ultra-High-MolecularWeight-Polyethylene (UHMWPE) articular component.

“The carpal implant assembly consists of a taper post component, a carpal plate, an articular component and two auxiliary bone screw components, all of which are metallic. The system is designed to replace the radiocarpal joint (distal radius and proximal row of carpal bones) and is intended to alleviate pain while restoring functionality and mobility of the joint.”

The company says 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.”

The device is a single-use implant intended to be used with bone cement.

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 the 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.”

Blanchard told OTW that this is another step forward in the company’s 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.”

The company intends to launch the system in 2021.