Orthoponents is the preferred supplier of manufacturing services for orthopaedic reconstructive medical devices. To support the medical device industry Orthoponents has employed the latest quality techniques and current Good Manufacturing Practices to ensure that our customer and regulatory requirements are achieved and maintained. Throughout the continual commitment to quality Orthoponents has previously gained certification to ISO 13485 and ISO 9001.
Earlier this year Orthoponents was subject to a US FDA Inspection, performed against the Quality System Regulations (QSR) for medical devices Title 21 Code of Federal Regulations (CFR) Part 820. The FDA Inspection of the Orthoponents site, in the New Forest, Hampshire, was a fundamental milestone for a Premarket Approval (PMA) application in order to support the objectives of Smith & Nephew Orthopaedics Ltd, Warwick, to allow the sale and distribution of the complete Birmingham Hip Resurfacing (BHR) System within in the US marketplace.
In recent years Orthoponents has been working to enhance the Quality Management System and business operations to achieve the highest quality standards and compliance against the latest industry regulations. At the point the FDA inspection was confirmed, Orthoponents developed and implemented a quality plan to finalise critical objectives to guarantee a successful outcome from the four day inspection, therefore ensuring that Smith & Nephew’s expectations were delivered. Orthoponents’ obligation to Smith & Nephew made certain that every aspect of the organisation would undergo review; collaborative continual improvement exercises were adopted to develop first class standards.
The Orthoponents team, in partnership with Smith & Nephew Orthopaedics Ltd, worked with vendors, independent consultants and industry experts, considerable investment and resources were planned into critical phases of preparation and ongoing controls to support FDA Regulatory requirements.
On the 14th October 2008 the US FDA gave final approval to the Smith & Nephew Orthopaedics Ltd PMA and to Orthoponents Ltd for compliance against 21 CFR 820, thus resulting in final product release of the complete BHR product range within the USA.
Marcus Daniels, Managing Director, commented ‘The FDA inspection has generated a wealth of experience for Orthoponents. As a subcontractor to the medical device industry we can now offer a unique service to our customers and provide first hand experience of the latest strategies, quality techniques and manufacturing controls. The FDA inspection approval is a testament to the expertise, hard work and discipline of the Orthoponents team, with particular mention to Steve Brown, QA & Development Manager. Every challenge was welcomed with a proactive approach and the organisation has achieved its ultimate aim. We now look forward to future targets, maintaining objectives and defining new ways to offer an optimum service to our customer base’.
FDA Approval Letter
FDA Report Letter