GENESIS II™ Knee System with OXINIUM to be marketed immediately.
Smith & Nephew, Inc., Orthopaedic Reconstruction & Trauma business and Smith & Nephew Orthopaedics KK Japan today announced that it has received Japanese regulatory C1 Category Reimbursement approval for it’s award winning OXINIUM™ oxidized zirconium technology. Smith & Nephew’s Genesis II OXINIUM™ Total Knee System is the first orthopaedic product to gain the C1 Category reimbursement in Japan, the world’s second largest orthopaedic market after the US. The C1 classification rewards innovative products with a higher reimbursement price and is reserved for those products where the advantages are recognized by the MHLW over other available products.Smith & Nephew’s Orthopaedics KK Japan first received regulatory approval for the Genesis II OXINIUM™ Total Knee System in Japan on February 18, 2008. Smith & Nephew is the only orthopaedic company to offer OXINIUM™, the revolutionary and award winning joint replacement material.
OXINIUM™ is a proprietary transformed metal alloy with a ceramic bearing surface that combines low friction and wear resistance technology with the strength of a metal implant. It is this ceramic surface that gives Oxinium its advantages over CoCr implants. Because only the surface is changed, the rest of the component is still metal and therefore the implant retains its overall strength. Currently Oxinium material is used for total hip and total knee joint replacements. This material is the only orthopaedic implant material to receive the ASM International Engineering Materials Award for outstanding achievement of a material used in the design and manufacture of products.
“Getting the GENESIS II Knee System with the OXINIUM Technology approved in Japan is a great opportunity for Smith & Nephew Orthopaedics KK Japan to offer a new state-of-the-art material to the Japanese patients and the surgeons who perform these procedures,” said Joseph M. DeVivo, president, Smith &Nephew Orthopaedic Reconstruction and Trauma. “We are pleased that the MHLW understood the benefits of Oxinium and we are also pleased by the MHLW’s C1 Category reimbursement, which recognizes the importance in making these types of new products available to the Japanese patient.”