Episurf Medical intends to submit a 510(k) application to FDA regarding the Episealer® Patellofemoral two-component system by the end of 2021. Product launch is expected in 2022.
Episurf Medical has initiated a development project to use the company’s imaging and CAD technology for the two-component system, comprising one implant for the trochlear area in the knee joint and one for patella. Both components will be individualized, cemented and have corresponding toolkits to ensure correct positioning.
The trochlear component will be similar to the present Episealer knee implant, and the patellar component will be a polymer implant.
“Since an opposing patellar cartilage lesion is a contraindication for using an Episealer® knee implant in the trochlear area, we see this project as a way to expand the market to a larger group of patients. Additionally, we expect that the 510(k) regulatory pathway will enable Episurf to enter the U.S. market significantly earlier than with the ongoing IDE study,” said Pål Ryfors, CEO, Episurf Medical.