DePuy Orthopaedics has announced that the FDA granted a supplemental pre-market approval to use special software to customize its Sigma RP knee implant for individual patients physiologies.
MassDevice reports the Johnson & Johnson subsidiary said the federal watchdog agency approved the use of its Trumatch Personalized Solutions system with its Sigma RP knee implant.
The FDA cleared the Trumatch software for the fixed-bearing Sigma implant in August 2011.
“We’re very excited about the opportunity to offer patients the world’s leading mobile bearing knee system, the Sigma RP knee, with Trumatch Personalized Solutions,” DePuy Orthopaedics President Andrew Ekdahl said in prepared remarks. “This approval means patients can now benefit from precise implant positioning, enabled by Trumatch Solutions, and the proven performance of both the Sigma RP and fixed-bearing knee systems, while increasing efficiency in the operating room.”