Stanmore Implants, a medical device manufacturer based in the United Kingdom, announced that it had received approval from the United States Food and Drug Administration for its Sculptor Robotic Guidance Arm. According to a press release by the company, the device is designed for use in partial knee resurfacing, also known as unicompartmental knee surgery.
In its press release, the company explained how the device works. According to Stanmore Implants, partial knee resurfacing is designed to only replace knee components that have worn out prematurely. Healthy tissue around the joint is retained. By retaining many of the ligaments surrounding the knee, partial knee resurfacing can help minimize the impact of a surgery on tissue.
In addition to reducing complications, partial knee surgery is a less invasive option than full knee replacement. With its Active Constraint technology, the Sculptor RGA can guide a cutting tool that limits the removal of bone to a safe area. The system comprises several different components. This includes special planning software, personalized implant development and a robotic implantation system.
Brian Steer is the executive chairman of Stanmore Implants. In prepared remarks, he said, "Following this FDA clearance for Sculptor RGA™ we are excited by the opportunity to bring our personalised approach to knee surgery to patients in the United States.” He continued, “Robotic technology represents a major advance in orthopaedics, providing accurate placement that is critical to implant longevity and reproducibility along with tangible cost benefits, making access to robotic surgery more widely available to patients.”