aap is granted FDA approval for Biorigid Nail Femur with CondyLock®

Metal and biological implants specialist aap Implantate AG has received U.S. market approval from the Food and Drug Administration (FDA) for its Biorigid Nail Femur with CondyLock®. aap is thereby extending its competence in the United States to the entire lower extremity range. Using the previously approved product system Biorigid Nail Tibia (BNT), both thigh and lower leg fractures can now be treated on the basis of a uniform principle.

In the Biorigid Nail Femur, aap has developed a future-oriented nail system that with its universal modular design and unique hybrid CondyLock® fixation makes it possible to apply different implantation techniques and new fixations to the thigh using a single nail that can be adjusted flexibly and intraoperatively to treatment requirements for the case in question.

World market volume for internal fixation products is estimated in Deutsche Bank Securities Inc.'s "Orthopedics 2002" report to total US$ 530 million, with an annual growth rate of 5% to 6%. Among internal fixation products, the intramedullary nail segment accounts for the largest market share of around US$ 300 million. In view of the FDA approval and other approval procedures that are under way, aap is hopeful of accelerated growth for the osteosynthesis segment in the United States, the world's largest trauma and orthopedics market.

The Biorigid Femur System (BFS) and Biorigid Nail Tibia (BNT) number among the most important product competencies in aap´s national and international sales strategy. In Asia aap booked over 17% of its consolidated first-half sales and the BFS accounted for a significant share of sales revenues.