Episurf Medical receives FDA 510(k) clearance for patellofemoral implant system
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Episurf Medical has announced FDA 510(k) clearance of the Episealer patellofemoral system, an implant system for patients with osteoarthritis limited to the distal patellofemoral joint, according to a company release.
The Episealer system, which is designed to replace both sides of the patellofemoral joint, can treat focal lesions in the cartilage and overt OA, according to the release.
“Gaining access to the U.S. market symbolizes a significant step for any orthopedic implant manufacturer,” Pål Ryfors, CEO of Episurf Medical, said in the release. “For Episurf, this clearance represents somewhat of a double milestone. Firstly, there is the obvious access to the U.S. orthopedic market, which is of significant size and by far the largest orthopedic market in the world. However, this clearance represents not only an additional country we are able to sell into, but a new product for the company as well – and our initial entry into treating OA as a clinical indication. The patellofemoral joint is one of the higher variance anatomic locations in the musculoskeletal system, and we’re confident our individualized technology will be able to play a meaningful role toward advancing care in this area,” Ryfors added.
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