Exactech, a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, has received Japan’s Ministry of Health, Labour and Welfare approval to market Novation primary hip replacement system in Japan, an orthopaedics market where hip replacement surgeries outnumber knee replacement procedures.
Exactech said that the approval is to market elements of the Novation comprehensive hip system, including the tapered femoral hip stem, femoral heads and bi-polar implants. Used by orthopaedic surgeons for primary hip replacement surgery, the implants represent one of the segments of the hip market in Japan.
The Novation hip system is designed to provide stability and range of motion for the patient and ease-of-use for the surgeon. Exactech is also pursuing approval for additional components within the product line, to support femoral and acetabular reconstruction.
Exactech said that the total hip replacement, also called total hip arthroplasty, involves removing a patient’s damaged bone and cartilage and replacing it with orthopaedic implants. A femoral stem implant is inserted into the hollow part of the thighbone. Femoral heads, bi-polar implants and acetabular components replace parts of the ‘ball and socket’ that comprise the hip joint.
David Petty, president of Exactech, said: “Expanding our hip implant sales in Japan is a significant opportunity and one for which we are well positioned. We have been providing total knee replacement products in Japan for more than a decade. In January 2008 we established a direct distribution operation for the Japanese market, and the addition of our Novation hip line allows us to further leverage that investment.”