The FDA has given Cardo Medical of Los Angeles marketing approval for the firm’s Align 360 Total Knee System, a device that the company says features a unique modular approach in implantation, done with common instruments familiar to surgeons:
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."
To learn more about the system, head to this product page: Align 360 Total Knee System
Press release: Cardo Medical Announces FDA Clearance of the Align 360 Total Knee System
Align 360 Surgical Technique (.pdf)…