Remarkable Orthopedic Products That Lead To Remarkable Patient Recoveries
XIROS (Ki-ros) Innovative Research for Orthopedic Surgery. Combining two to become one, Xiros collaborates with innovative surgeons in developing today’s and tomorrow’s surgical solutions. These are remarkable products that lead to remarkable patient recoveries with over three million benefiting from our technology.
Our singular objective: Improve patient outcomes by delivering innovative, implantable textiles and devices.
Pioneers Of Orthopedic Devices
For nearly four decades Xiros has designed, developed, manufactured, and marketed state-of-the-art implantable orthopedic medical devices. Leveraging the experience and design involvement from the world’s best surgeons, Xiros has literally changed the lives of millions of patients—enabling long-term, favorable outcomes who now enjoy the freedom of a healthy lifestyle.
A Heritage Of Unwavering Dedication
Established in 1982 in Leeds, UK, Xiros, Ltd., is a leading British medical device company specializing in the design, development, manufacture, and supply of implantable textile-based scaffolds for the sports medicine and orthopedic markets.
The company was launched following the successful development of the Leeds-Keio Ligament: a result of collaborative research between Dr. Bahaa Seedhom of the Rheumatology and Rehabilitation Research Unit at Leeds University and Dr. Kyosuke Fujikawa of the Department of Orthopedic Surgery at Keio University in Tokyo.
Since those early days of development, the Xiros portfolio has grown to include an extensive range of products for a wide range of ligament, tendon, and soft tissue injuries.
Premier International Certifications
The sterile implantable scaffolds are manufactured in-house at our state-of-the-art factory premises in Leeds, under a strict, quality management system that operates to meet or exceed a number of international standards.
In 1993 Xiros Ltd., was registered by the British Standards Institution (BSI) to ISO 9001, and in 1995 to EN 46001. This enabled us to become one of the first UK companies eligible to CE mark its products under the EU Medical Device Directive.
In 2004 Xiros Ltd., gained accreditation to ISO 13485. We have also been successfully inspected by the FDA. In 2018 we superseded our ISO 9001 certification, while continuing to maintain our ISO 13485 certification.
Copies of our ISO certificates are available to view below:
The Xiros Millennium
In 2000 we changed our company name to Xiros (pronounced Ki-ros) to reflect our unique and diverse range of skills, which include research, engineering and regulatory knowledge of medical implantable devices. An acronym for Innovative Research in Orthopedic Surgery, Xiros brings together innovative minds and textile manufacturing to achieve outstanding results.
Although we continue to design, manufacture, and market our product lines under the brand name of Neoligaments, as Xiros we also specialize in development and manufacture of products for other orthopedic companies as well as developing, manufacturing and distributing products under the Xiros brand name.
Xiros Inc., (North America) was launched in 2019 to meet the implantable orthopedic needs of the United States and Canada by leveraging nearly four decades of innovation and remarkable patient outcomes.
Total Quality & Top-tier Facilities
Xiros Ltd., operates under a strict quality management system that adheres to a number of international standards. In 1993 Xiros Ltd., was registered by the British Standards Institution (BSI) to ISO 9001, and in 1995 to EN 46001.
This enabled us to become one of the first UK companies eligible to CE mark its products under the EU Medical Device Directive. In 2004 we gained accreditation to ISO 13485. In 2018 we superseded our ISO 9001 certification, while continuing to maintain our ISO 13485 certification.
In meeting these rigorous standards we consistently supply high quality products that meet the needs of our customers and clients, the surgeons who implant them, and the patients whose quality of life is improved by receiving them.
Our textile implants are manufactured in-house at our state-of-the-art factory premises in Leeds, UK. Each product is cleaned by specially developed processes before final preparation, inspection and packaging in our ISO 14644-1 Class 7 Clean Room.
This facility is supported by our own in-house microbiological service. All of our implants are supplied within a double blister pack or double pouch pack to allow protection for the intended shelf life, and then sterilized by a validated gamma irradiation process.
Xiros Inc., (North America) maintains a quality management system in accordance with the guidelines and requirements of the U.S. Food and Drug Administration (FDA).
We are dedicated to maintaining our excellent and long-standing reputation for quality and regulatory compliance. Throughout our history we have been successfully inspected by a number of important regulatory bodies including the FDA and BSI. We look forward to undergoing future audits and inspections, and continuing to prove ourselves as a company that doesn’t compromise when it comes to quality.
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