The US FDA has granted approval to Corentec America, a wholly-owned subsidiary of Seoul-based Corentec Co., Ltd., to market its novel Lospa Knee System in the United States. This innovative knee joint replacement system is available now, along with the currently available total hip replacement system, and a pedicle screw system for spine.
Corentec will unveil the Lospa Knee System, and the company's portfolio of Hip and Knee Joint Implants at the North American Spine Society (NASS) Annual Meeting in Dallas, October 24-27 and at the American Association of Hip and Knee Surgeons (AAHKS) Meeting, in Dallas, November 2-4, 2012, as well as the company's innovative solutions at the American Academy of Orthopaedic Surgeons Meeting, in Chicago, March 19-23, 2013.
Product extensions for the company's already cleared Bencox THR System and spinal implants are in the process of US FDA clearance, or in the development pipeline for the US market.
"Corentec America has successfully completed a number of cases in the US using the Lospa Knee System," said Michael Y Son, vice president, Corentec America, Inc. Son further added, "The feedback from leading surgeons has been outstanding, exactly as we expected. Surgeons have commented on the positive attributes of the Lospa Knee System, including the wide range of options allowing for patient variables, and in particular, surgeons have made affirmative comments as to the ease-of-use, and intuitiveness of our instrumentation."
Son informed that Corentec is now poised to enter the next roll-out phase for the Lospa Knee System by reaching more distributors and surgeons. The Lospa Knee System is available with a robust catalog of instruments designed to ensure ease-of-use in the OR, and a more efficient surgical procedure.
Manufactured in state-of-the-art facilities located in South Korea, the Lospa Knee System offers an anatomically featured shape for both a cruciate retaining (CR) and a posterior stabilized (PS) knee within a single system. This ensures successful patient outcomes with natural knee range of motion and increased longevity of the implant.
The Femoral Component of the Lospa Knee System is designed with a single axis concept for articular stability with flexion for improved range of motion. The anterior flange shape and dimension provides optimal patella tracking. The intercondylar cam design of the PS type is to prevent dislocation in deep flexion. The sphere-shaped articular surface design ensures reduced contact stress and improved stability.
A Curved on Curved Tibial Insert is designed to provide high conformity at the frontal plane to maximize contact area. Double radius at the sagittal plane ensures anterior stability and deep flexion. The Rotated articular track for CR and PS versions allows optimal rotation of the femoral component. In the case of PS type, the tibial post is designed to reduce edge loading. The Tibial insert also allows for improved anterior relief for deep flexion.
The Tibial Baseplate, for fixed-CR and Fixed-PS, features a stem with a keel for improved initial implant stability. The stem has a posterior slope to avoid anterior cortex impingement. A precision ground finish on the Tibial Baseplate allows for full peripheral capture to reduce micromotion. The ground finish of the Tibial Baseplate insert mating plane is designed for decreased backside wear.
The 30mm Patellar Component Dome is available in six sizes (26mm, 28mm, 30mm, 32mm, 34mm and 36mm). Three fixation pegs are uniform for all sizes. Cement pockets provide an optimal condition for cemented fixation. The cement pocket is 1mm in depth, but is not deep enough to compromise the strength of the component. There is reinforcement in the centre of the pocket and peripheral rim, also with a 1mm thickness.
Corentec offers six Tibial inset sizes (Fixed Bearing Couple), in combination with 16 Femoral component sizes. There are six CR Type, and six PS Fixed Type size combinations.
Son said, "Corentec is continuing our programme to establish a network of highly successful distributors who possess deep relationships with leading surgeons.” Son further added, "As we move forward with distribution of Corentec's advanced solutions for Knee, Hip, and Spine, we will be offering highly competitive commission rates to high-producing distributors throughout the US."