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Osteotec commenced re-launch of the Osteotec Silicone Finger Implant in markets accepting CE-Marked medical devices, following its successful certification under the European Medical Device Regulation.
This milestone was achieved after two years of regulatory work by Osteotec’s legal, quality and regulatory teams, and underscores the company’s commitment to providing high-quality, British-made solutions in an increasingly complex regulatory environment.
The Osteotec Silicone Finger Implant has remained available and widely used in FDA markets, and the reintroduction of CE certification is expected to drive global sales and increase access to the product for surgeons worldwide.
The one-piece, sterile, flexible silicone elastomer implant has been designed for arthroplasty of the metacarpophalangeal and proximal interphalangeal joints, offering a solution for osteoarthritis, rheumatoid arthritis or joint trauma.
The Osteotec Silicone Finger Implant has been widely used in hand surgery over the past two decades, delivering consistent, positive outcomes for patients requiring joint replacement due to arthritis or trauma since it was launched in 2004.
“We are incredibly excited to reintroduce the Osteotec Silicone Finger Implant to both our UK and international customers,” said Anthony McClellan, Group General Manager of Osteotec. “Navigating the MDR transition has been a significant challenge for the entire industry, and particularly for independent businesses.
“However, thanks to our dedicated teams and our strong partnerships with our notified body TÜV SÜD and the Compliant Medical Devices Ltd consultancy, we’ve been able to meet these regulatory requirements and continue offering a world-class solution for small joint arthroplasty.”
“As a proud UK-based manufacturer, we have made a substantial investment to ensure the long-term availability of this essential product,” said Dean Stockwell, Sales and Marketing Director at Osteotec.
“The Osteotec Silicone Finger Implant stands out as a British innovation that delivers tangible benefits to surgeons and patients alike. Our re-launch comes at a time when the regulatory environment has made it increasingly difficult for independent companies to thrive, but we remain committed to improving patient outcomes both in the UK and internationally.”
Source: Osteotec
Osteotec commenced re-launch of the Osteotec Silicone Finger Implant in markets accepting CE-Marked medical devices, following its successful certification under the European Medical Device Regulation.
This milestone was achieved after two years of regulatory work by Osteotec's legal, quality and regulatory teams, and underscores the company's...
Osteotec commenced re-launch of the Osteotec Silicone Finger Implant in markets accepting CE-Marked medical devices, following its successful certification under the European Medical Device Regulation.
This milestone was achieved after two years of regulatory work by Osteotec’s legal, quality and regulatory teams, and underscores the company’s commitment to providing high-quality, British-made solutions in an increasingly complex regulatory environment.
The Osteotec Silicone Finger Implant has remained available and widely used in FDA markets, and the reintroduction of CE certification is expected to drive global sales and increase access to the product for surgeons worldwide.
The one-piece, sterile, flexible silicone elastomer implant has been designed for arthroplasty of the metacarpophalangeal and proximal interphalangeal joints, offering a solution for osteoarthritis, rheumatoid arthritis or joint trauma.
The Osteotec Silicone Finger Implant has been widely used in hand surgery over the past two decades, delivering consistent, positive outcomes for patients requiring joint replacement due to arthritis or trauma since it was launched in 2004.
“We are incredibly excited to reintroduce the Osteotec Silicone Finger Implant to both our UK and international customers,” said Anthony McClellan, Group General Manager of Osteotec. “Navigating the MDR transition has been a significant challenge for the entire industry, and particularly for independent businesses.
“However, thanks to our dedicated teams and our strong partnerships with our notified body TÜV SÜD and the Compliant Medical Devices Ltd consultancy, we’ve been able to meet these regulatory requirements and continue offering a world-class solution for small joint arthroplasty.”
“As a proud UK-based manufacturer, we have made a substantial investment to ensure the long-term availability of this essential product,” said Dean Stockwell, Sales and Marketing Director at Osteotec.
“The Osteotec Silicone Finger Implant stands out as a British innovation that delivers tangible benefits to surgeons and patients alike. Our re-launch comes at a time when the regulatory environment has made it increasingly difficult for independent companies to thrive, but we remain committed to improving patient outcomes both in the UK and internationally.”
Source: Osteotec
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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.
