FDA Clears Exactech’s Computer-Assisted Shoulder Arthroplasty Tech

Exactech Inc., a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee, and hip, announced it has received clearance from the U.S. Food and Drug Administration to market the ExactechGPS Shoulder Application. Combining preoperative planning with computer-assisted surgery, the technology allows for greater intraoperative visibility in both standard and challenging shoulder arthroplasty.
 
“The ExactechGPS Shoulder Application offers groundbreaking technology that is unique to the industry and should continue our selling momentum that delivered 21 percent growth in the first quarter,” said Darin Johnson, vice president, extremities marketing. “Allowing surgeons to preoperatively plan the surgery and then execute it with a computer-assisted solution will help patients by ultimately improving outcomes. Importantly, it also reflects Exactech’s philosophy of keeping intraoperative decision making and control in the surgeon’s hands.”
 
An introduction to the new technology was the focal point at the recent 2017 Exactech Shoulder Masters Course, with live broadcasts of two surgeries performed by Pierre-Henri Flurin, M.D., in Bordeaux, France.
 
“The live surgeries featuring the new ExactechGPS shoulder application for both anatomic and reverse total shoulder cases were incredible as it felt like we were in the operating room. It was exciting to witness the most advanced innovation in shoulder arthroplasty since reverse shoulders were first introduced,” said attendee Samuel Antuña, M.D.
 
Setting a new standard in medical education, the Masters Course’s comprehensive scientific program featured 35 presentations by distinguished faculty who shared their experiences and philosophies with more than 150 surgeons from 17 countries around the world. Faculty member Joseph Zuckerman, M.D., said, “This was one of the highest quality educational meetings I have participated in during my professional career. Between the scientific and technical presentations, debates, live surgeries and interactions between our surgeon peers, it was a truly unique and rewarding experience.”
 
The ExactechGPS Shoulder Application’s preoperative planning tool is designed to help surgeons understand their patient’s anatomy prior to surgery. Intraoperatively, ExactechGPS provides visibility into the glenoid vault in real time and allows for consistent, accurate glenoid placement.¹ A recent study showed that more accurate glenoid placement minimizes complications and theoretically increases implant survivability.² In addition, ExactechGPS provides a real-time view of retroversion and inclination, reaming and drilling depth, screw placement and the ability to adjust surgical plan intraoperatively, offering surgeons more flexibility.
 
The ExactechGPS Shoulder Application has been used successfully in the U.K., Spain, France and Australia. The initial launch in the U.S. is planned for this quarter. It is the latest addition to the Equinoxe Shoulder System, which has been one of the fastest growing shoulder lines on the market since its introduction more than a decade ago. This year marks the 10th anniversary of the first implantation of the Equinoxe reverse shoulder; Equinoxe products will be implanted in the 100,000th patient before the end of this year.
 
References
¹Data on file at Exactech
²Walch G et al. Results of a convex-back cemented keeled glenoid component in primary osteoarthritis: multicenter study with a follow-up greater than 5 years. J. Shoulder and Elbow Surg. (2011) 20; 385-394.