Stanmore Implants has received 510(k) clearance from the FDA to market its Sculptor Robotic Guidance Arm for precision implant replacement in unicompartmental knee surgery.
According to a company press release, the Sculptor RGA uses a robotic guidance arm to assist the surgeon’s operation of a cutting tool, limiting the removal of bone to a predefined safe area using Stanmore’s patent protect Active Constraint technology. While bone is removed corresponding to the implant shape during surgery, a tracking arm determines and monitors the location of the patient ensuring that the surgeon accurately prepares the bone surface to match the implant.
The Sculptor RGA will be introduced in the United States for unicompartmental knee surgery in a limited release to a select group of surgeons in mid-2013.
“Robotic technology represents a major advance in orthopedics, 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,” Brian Steer, executive chairman of Stanmore, stated in the release.