Exactech Receives 510(k) Clearance for Equinoxe® Stemless Shoulder

Tuesday, Mar 13, 2018

Exactech, a leading developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today it has received clearance from the U.S. Food and Drug Administration to market the Equinoxe® Stemless Shoulder, a bone conserving and canal sparing prosthesis that is compatible with the Equinoxe® Shoulder System. The Stemless Shoulder is the latest addition to the company’s extremities product line.

“Our world-class design team and engineers deserve a lot of praise for this new product, and in particular, for an efficient product development process. Their ingenuity, coupled with their passion for clinical outcomes, allowed them to navigate this product to market very quickly, and is emblematic of our mission to help patients,” said Darin Johnson, Exactech vice president of marketing for extremities.

Designed for anatomic total shoulder arthroplasty, the Stemless Shoulder features a single tray of instruments for operating room efficiency. It uses a three-dimensional porous structure with optimized pore size, count and porosity. In addition, the Stemless Shoulder incorporates a bone cage for bone through-growth to enhance the probability of biologic fixation.

“The Stemless Shoulder’s innovative combination of three-dimensional porous material and bone cage technology help differentiate it from others on the market,” said design team member Buddy Savoie III, MD, of Tulane University. “Exactech’s ability to convert design team concepts and ideas into a reality is quite impressive, and I am certain surgeons will be eager to learn more about this meaningful technology.”

Joining Dr. Savoie on the design team were Pierre-Henri Flurin, MD, of Clinique du Sport in Bordeaux-Mérginac, France; Curtis Noel, MD, of Crystal Clinic Orthopaedic Center in Akron, Ohio; Ryan Simovitch, MD, of Palm Beach Orthopaedic Institute in Palm Beach Gardens, Fla.; Thomas Wright, MD, of the University of Florida; and Joseph Zuckerman, MD, of NYU Langone Orthopaedic Hospital.

Exactech plans to initiate targeted clinical evaluation of the Stemless Shoulder immediately, and will aggressively expand the release throughout the second half of the year.