FDA Clears Corentec Knee System
Corentec America Inc., a wholly-owned subsidiary of Seoul, South Korea-based Corentec Company Ltd., has received U.S. Food and Drug Administration (FDA) clearance to market the Lospa Knee System in the United States. The knee replacement system currently is available along with the company’s total hip replacement (THR) system and a pedicle screw system for spine. Product extensions for the Corentec’s already-cleared Bencox THR System and spinal implants are in the process of FDA clearance or in the development pipeline for the U.S. market.
“Corentec America has successfully completed a number of cases in the United States using the Lospa Knee System,” said Michael Y. Son, vice president of Corentec America Inc. “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. 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 catalog of instruments designed to ensure ease-of-use in the operating room, and a more efficient surgical procedure.
Lospa Knee System is manufactured in South Korea, and is shaped for both a cruciate retaining (CR) and a posterior stabilized (PS) knee within a single system. This reportedly 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 company claims. The intercondylar cam design of the PS type is to prevent dislocation in deep flexion. The sphere-shaped articular surface design is intended to reduce contact stress and improved stability.
The curved tibial insert is designed to provide high conformity at the frontal plane to maximize the contact area. Double radius at the sagittal plane ensures anterior stability and deep flexion, and the rotated articular track for CR and PS versions is designed to allow 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 reportedly 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 30-mm patellar component dome is available in six sizes (26 mm, 28 mm, 30 mm, 32 mm, and 34 mm). Three fixation pegs are uniform for all sizes. The cement pockets for cement fixation are 1 mm in depth, but are not deep enough to compromise the strength of the component, claims Corentec. There is also 1-mm reinforcement in the center of the pocket and peripheral rim.
Corentec’s international headquarters is in Seoul and Corentec America is based in Irvine, Calif. The company provides a range of joint replacement products.