FORT WAYNE, IN —BioPoly LLC, has received official notice of its CE mark for its partial resurfacing knee product line, allowing the company to market these products in Europe, according to company officials. As a result, the company is planning to launch the BioPoly™ RS Partial Resurfacing Knee Implant system in Europe later this year. BioPoly LLC already received ISO 13485 certification for its quality system last year and has been working diligently to complete all of the tasks necessary to obtain CE certification for the partial resurfacing knee system. Janine Campbell, Ph.D., Director of Science and Regulatory Affairs, said, “Receiving the CE mark is a remarkable accomplishment and culmination of years of dedication by the research, engineering and regulatory/quality teams. We are excited to bring this innovative product to the EU market.”
BioPoly™ is a proprietary material that combines two well-known orthopaedic materials; a synthetic polymer and a naturally occurring polysaccharide. This unique combination creates a self-lubricated polymer that interacts very favorably with orthopaedic tissues. By utilizing these characteristics, the BioPoly™ RS Partial Resurfacing Knee Implant replaces only the damaged portion of the knee joint, leaving the rest of the joint tissues intact.
Additional products that make use of the BioPoly material characteristics in other joints throughout the body are under development for use in Europe as well as in the US.
About BioPoly
BioPoly LLC is an orthopaedic implant company located in Fort Wayne, Indiana. The company is developing and manufacturing products for use in the sports medicine, orthopaedics, and spinal markets.