FDA clears DePuy fixed-bearing knee surgical system
DePuy Orthopaedics has received FDA 510(k) clearance for the use of Trumatch Personalized Solutions, a surgical instrumentation and computer software system, with the company’s Sigma Fixed-Bearing Knee System.
Trumatch is available for immediate use and is designed to aid in knee implant positioning and procedures, DePuy stated in a release. Trumatch utilizes CT scans and computer software to guide the development and production of femoral and tibial cutting blocks that are individually prepared to match the actual bone surfaces of each patient.
The FDA clearance was based in part on mechanical and alignment accuracy testing, according to DePuy, and the system is currently available in 12 other countries.
Trumatch is available for immediate use and is designed to aid in knee implant positioning and procedures, DePuy stated in a release. Trumatch utilizes CT scans and computer software to guide the development and production of femoral and tibial cutting blocks that are individually prepared to match the actual bone surfaces of each patient.
The FDA clearance was based in part on mechanical and alignment accuracy testing, according to DePuy, and the system is currently available in 12 other countries.