The US Food and Drug Administration (FDA) has granted 510(k) clearance to Stanmore Implants' Sculptor Robotic Guidance Arm (RGA) for unicompartmental knee replacement surgery, also known as partial knee resurfacing.
Partial knee resurfacing, which is less invasive compared to total knee replacement, is a preservation technique, which replaces the parts of the knee that are worn out and painful, retains the natural ligaments around the knee and reduces surgical damage to tissue, claims the company.
Using the company's patent protected Active Constraint technology and a robotic guidance arm, Sculptor RGA determines and monitors the location of the patient ensuring that the surgeon accurately prepares the bone surface to match the implant precisely.
During the clinical studies, Active Constraint technology has shown to provide better functional outcome at 7 year follow up for partial knee surgery compared to the saws and jigs currently used in knee surgery procedures.
The company said the product will be launched in the US in a limited release to a select group of surgeons from mid-2013, as it is continuing its evidence based approach to new product introduction.
In addition, Stanmore is developing additional applications for Sculptor RGA to expand the commercialization for the next year.
Stanmore Implants executive chairman Brian Steer said, "Stanmore is now looking forward to working further with surgeons to continue to develop innovative solutions for the global orthopaedic market."
