Exactech has 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.
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.
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.