U.K.-based orthopedic device maker Stanmore Implants says it has received FDA clearance for its Sculptor Robotic Guidance Arm system for partial knee resurfacing procedures.
The system uses a robotic guidance arm to assist surgeons’ operation of cutting tools, and "limiting the removal of bone to a pre-defined safe area," according to a prepared release. It is part of a suite of devices and software systems the company produces for personalized orthopedic implants.
Stanmore says it will release the system in a limited number of hospitals starting in mid-2013 and are investigating more applications.
"We are excited by the opportunity to bring our personalised approach to knee surgery to patients in the United States," chairman Brian Steer said in a prepared release. "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."
Last year, Stanmore raised the hackles of Burlington, Mass.-based ConforMIS, which filed documents officially contesting its U.K. rivals patent application, after it claimed to be the world’s 1st personalized knee implant.
"ConforMIS strongly disagrees with the recent claim in a press release issued by Stanmore and Imperial Innovations Group that they are developing the ‘world’s first fully personlized early knee replacement surgery system,’ and ConforMIS has filed papers that will help set the record straight," ConforMIS CEO Philip Lang said in prepared remarks.