Exactech announced today that the FDA granted a breakthrough device designation to JointMedica’s Polymotion hip resurfacing system.
Gainesville, Florida-based Exactech, a minority shareholder of JointMedica, collaborates with the United Kingdom-based orthopedic device designer and manufacturer on next-generation hip resurfacing and holds exclusive global distribution rights to the product.
“This designation by the FDA is a validation of our core belief at JointMedica—that our hip resurfacing device addresses an acute unmet need of relatively younger, active hip arthritis patients,” JointMedica Managing Director Terence Smith said in a news release.
Polymotion features advanced polyethylene and titanium manufacturing technology, Exactech said. It was designed to offer the biomechanical benefits of hip resurfacing while eliminating metal-on-metal articulating surfaces.
“We are thrilled that Polymotion and JointMedica have been recognized as one of only 71 orthopedic devices that have received breakthrough designation since the inception of this program,” Exactech Chief Strategy Officer Dr. Sharat Kusuma said. “We aspire to accelerate Polymotion hip resurfacing development and help more patients get back to all the activities they love.”