Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation for JointMedica’s Polymotion® Hip Resurfacing System.
Exactech, a minority shareholder of JointMedica Limited, is collaborating with the United Kingdom-based orthopaedic device designer and manufacturer to deliver the next generation of hip resurfacing to the global market, 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,” said Terence Smith, Managing Director of JointMedica.
According to Exactech Chief Strategy Officer, Sharat Kusuma, MD, “We are thrilled that PolyMotion and JointMedica have been recognized as one of only 71 orthopaedic devices that have received breakthrough designation since the inception of this program. We aspire to accelerate Polymotion hip resurfacing development and help more patients get back to all the activities they love.”
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
“Hip Resurfacing remains an excellent choice for young, active patients, who will inevitably place a higher demand on their hip reconstruction. The introduction of metal-on-vitamin E crosslinked polyethylene hip resurfacing would be most welcomed by me as a practicing surgeon and well-received by my patient community,” said Craig J. Della Valle, MD, of Midwest Orthopaedics at Rush in Chicago, Illinois.
Dr. Della Valle is joined by colleague Scott Marwin, MD, of NYU Langone Orthopedic Hospital, in an advisory role in submitting for the breakthrough designation.
“Through this deep collaboration Exactech and JointMedica are well positioned to bring the Polymotion Hip Resurfacing System to the global market. Partnering with surgeons at the early stages of development has always served a fundamental role in our success,” said Jeff Binder, CEO and Chairman of the Board of Exactech. “Polymotion will complement Exactech’s Alteon® hip arthroplasty portfolio, comprised of substantial advancements in design and materials to time-tested solutions.”
With more than three decades of experience using hard-on-hard articulations in hip resurfacing, Derek McMinn MD, FRCS, and Ronan Treacy, MD, FRCS, designed the Polymotion Hip Resurfacing System to leverage the clinically successful design principles of their previous hip resurfacing devices, now with advanced polyethylene and titanium manufacturing technology. The Polymotion hip offers the biomechanical benefits of hip resurfacing but eliminates metal-on-metal articulating surfaces.