08.19.11
DePuy Orthopaedics Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its TruMatch Personalized Solutions with the company’s Sigma Fixed-Bearing Knee System. TruMatch, a surgical instrumentation and computer software system designed to aid in knee implant positioning and procedure efficiency, will be available immediately. Clearance was based partly on mechanical and alignment accuracy testing.
According to DePuy, the TruMatch System eliminates up to nine surgical steps compared to total knee replacements performed without the System, reducing operating room time by an average of 35 minutes.
“TruMatch Personalized Solutions represents an advance for knee replacement patients,” said Andrew Ekdahl, president, DePuy Orthopaedics. “This system is a win for patients, surgeons and hospitals that has the potential to improve patient care while reducing costs—
a very important combination in health care today.”
The System is the first to utilize computed tomography (CT) scans and computer software to guide the development and production of femoral and tibial cutting blocks made to match the actual bone surfaces of each patient, according to DePuy. The company also claims that the use of CT scans rather than magnetic resonance imaging results in improved bone imaging, less scanning time and lower costs.
According to DePuy, the TruMatch System eliminates up to nine surgical steps compared to total knee replacements performed without the System, reducing operating room time by an average of 35 minutes.
“TruMatch Personalized Solutions represents an advance for knee replacement patients,” said Andrew Ekdahl, president, DePuy Orthopaedics. “This system is a win for patients, surgeons and hospitals that has the potential to improve patient care while reducing costs—
a very important combination in health care today.”
The System is the first to utilize computed tomography (CT) scans and computer software to guide the development and production of femoral and tibial cutting blocks made to match the actual bone surfaces of each patient, according to DePuy. The company also claims that the use of CT scans rather than magnetic resonance imaging results in improved bone imaging, less scanning time and lower costs.