South Korean Knee Prosthesis Gains FDA Clearance

In short

Corentec America, Inc., a wholly-owned subsidiary of Seoul-based Corentec Co., Ltd., has announced the FDA clearance of its novel Lospa Knee System® in the United States.

The innovative Knee Joint Replacement System is available now, along with the currently available Total Hip Replacement System, and a Pedicle Screw System for spine. Product extensions for the Company’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.


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 stabilised (PS) knee within a single system, the goal being successful patient outcomes with natural knee range of motion and increased longevity of the implant.

Highlights in what is a feature packed sales pitch of a press release include the Femoral Component design which is a single axis concept for articular stability with flexion for improved range of motion. Further, its “Curved on Curved” Tibial Insert is designed to provide high conformity at the frontal plane to maximise contact area.

Six Tibial inset sizes are offered(Fixed Bearing Couple), in combination with 16 Femoral component sizes. There are six CR Type, and six PS Fixed Type size combinations.

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.

Company comments

“Corentec America has successfully completed a number of cases in the U.S. using the Lospa Knee System,” said Michael Y. Son, vice president, 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.” Mr. Son added, “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.”

“Corentec is continuing our program to establish a network of highly successful distributors who possess deep relationships with leading surgeons,” said Mr. Son. “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 U.S.”

Source: Corentec America, Inc., PR Newswire