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Episurf Medical received FDA 510(k) clearance to market the Episealer® Patellofemoral System.
The system provides two opposing implants, intended for patients with osteoarthritis limited to the distal patellofemoral joint in the knee. It is based on Episurf Medical’s proprietary individualized implant technology.
Episurf Medical will now prepare for the market launch of the company’s first product in the U.S. market.
“Episurf has received U.S. market clearance from FDA for our patellofemoral implant system. To date, this likely represents the single most significant milestone in the company’s history. The company now has access to the largest and most dynamic orthopaedic market in the world and we have come a very long way, indeed, since our first animal investigations nearly 15 years ago. The patellofemoral implant system replaces both sides of the patellofemoral joint of the knee. This means that our technology can now treat not only focal lesions in the cartilage but also overt osteoarthritis. Hence, we can now serve a broader span of indications,” said Prof. Leif Ryd, Senior Medical Advisor, Episurf Medical.
“Gaining access to the US market symbolizes a significant step for any orthopaedic implant manufacturer. For Episurf, this clearance represents somewhat of a double milestone. Firstly, there is the obvious access to the US orthopaedic market, which is of significant size and by far the largest orthopaedic 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 osteoarthritis 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 towards advancing care in this area,” said Pål Ryfors, CEO Episurf Medical.
Source: Episurf Medical
Episurf Medical received FDA 510(k) clearance to market the Episealer® Patellofemoral System.
The system provides two opposing implants, intended for patients with osteoarthritis limited to the distal patellofemoral joint in the knee. It is based on Episurf Medical’s proprietary individualized implant technology.
Episurf Medical will now...
Episurf Medical received FDA 510(k) clearance to market the Episealer® Patellofemoral System.
The system provides two opposing implants, intended for patients with osteoarthritis limited to the distal patellofemoral joint in the knee. It is based on Episurf Medical’s proprietary individualized implant technology.
Episurf Medical will now prepare for the market launch of the company’s first product in the U.S. market.
“Episurf has received U.S. market clearance from FDA for our patellofemoral implant system. To date, this likely represents the single most significant milestone in the company’s history. The company now has access to the largest and most dynamic orthopaedic market in the world and we have come a very long way, indeed, since our first animal investigations nearly 15 years ago. The patellofemoral implant system replaces both sides of the patellofemoral joint of the knee. This means that our technology can now treat not only focal lesions in the cartilage but also overt osteoarthritis. Hence, we can now serve a broader span of indications,” said Prof. Leif Ryd, Senior Medical Advisor, Episurf Medical.
“Gaining access to the US market symbolizes a significant step for any orthopaedic implant manufacturer. For Episurf, this clearance represents somewhat of a double milestone. Firstly, there is the obvious access to the US orthopaedic market, which is of significant size and by far the largest orthopaedic 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 osteoarthritis 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 towards advancing care in this area,” said Pål Ryfors, CEO Episurf Medical.
Source: Episurf Medical
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
