FDA Clears Align 360 Total Knee System
Cardo Medical (OTC Bulletin Board: CKST), a company engaged in the development of orthopedic medical devices, announces the FDA 510k clearance of its Align 360 Total Knee System.
The Align 360 Total Knee System is planned for commercial release during the second quarter of 2009. Cardo Medical's innovative Total Knee System is the flagship product within its Align 360 platform, which has already received FDA clearance for its Uni-Compartmental and Patello-Femoral systems. All three systems feature a unique modular approach and common instrumentation system with a revolutionary concept designed to deliver simplified, reproducible surgical outcomes. Cardo Medical's Uni-Compartmental System, which was the first product release within the Align 360 platform, has been used successfully in over 500 surgeries to date.
John Kuczynski, Cardo Medical's Vice-President of Research and Development, commented: "The Align 360 Total Knee System is truly an advanced knee platform. Its femoral component features a funnel-shaped patella track that accommodates the quadriceps angle anatomy for both male and female patients, without the need for gender specific components which provides a tremendous inventory savings for all operating rooms. In addition, the anterior geometry of the femoral component has been designed to reduce antero-medial overhang of the femoral component, which has been clinically proven to be a cause of post-operative knee pain."
Dr. Andrew Brooks, Chairman and Chief Executive Officer of Cardo Medical, stated: "We are pleased to have achieved this regulatory milestone and are excited to have rounded out our Align 360 platform. Our Total Knee System builds upon our Uni-compartmental and Patella-Femoral systems and is designed as a high performance treatment for tri-compartmental arthritis with choice of either a cruciate sparing or posterior stabilizing device. We now have a unique and comprehensive knee system which allows the surgeon to use matched instrumentation for surgical treatment of uni-compartmental, bi-compartmental and tri-compartmental arthritis. Our Align 360 platform boasts a common, modular instrument set and component design heritage and philosophy. Our novel, minimally invasive instrumentation is designed to enable surgeons to achieve superior surgical outcomes. Cardo Medical looks forward to introducing these and other orthopedic design innovations to the US market over the upcoming quarters."