South Korean Firm Breaks Into U.S. Ortho Market

There’s been a lot of news lately about U.S. companies looking to international markets and regulatory approvals overseas to circumvent an increasingly unpredictable medical device approval process from the U.S. Food and Drug Administration (FDA) here at home.

But here’s a twist we don’t hear about as often—an orthopedic breaking into the highly competitive U.S. hip, knee and spine markets.

Corentec Co. Ltd., a Seoul, South Korea-based medical device company is now based offering its orthopedic products in the United States with the launch of its wholly owned subsidiary, Corentec America Inc. in Irvine, Calif.

The announcement was made on the opening day of the 79th Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) in San Francisco, Calif.

In addition to its implants, the company also plans to sell its line of instruments, used by orthopedic surgeons and neurosurgeons.

Michael Y. Son, vice president, Corentec America Inc., will lead the company’s sales and marketing efforts.

At AAOS, Corentec is, of course, highlighting its products already cleared for use in the United States. Products available immediately include a total hip and bipolar hip implants and a pedicle screw system. A total knee implant is awaiting FDA clearance, which the company predicts it will receive in the first quarter of this year. Additional products for hip, knee and spine currently are in the FDA clearance process and will be available later this year.

The company’s manufacturing currently is done in South Korea, where, according to company executives, the firm currently holds the leading market position for total hip arthroplasty in South Korea.

Given Corentec’s recent past history at AAOS, the announcement last year, seemed like a natural fit.

At last year’s meeting, the company’s founding surgeons presenting a scientific paper that received the Otto Aufranc Award, which is presented for “innovative research, either clinical or basic, encompassing important advances in the management of hip disorders.”

Corentec’s paper focused on the company’s patented surface treatment technology, containing calcium and phosphate, the natural building blocks of bones, to enhance and maximize bone ingrowth.

“Our expansion into the U.S. market is yet another milestone for our company,” said Sung Taek Hong, CEO of Corentec Co. Ltd. “We have great expectations for Corentec America. “Through collaboration among a team of world-renowned orthopedic surgeons, academic leaders, scientists, and R&D engineers, Corentec has successfully developed a portfolio of hip and knee joint implants, spine implants and instruments that are recognized by the company’s customers for their high quality and reliability.”

Hong said as his company grows, the U.S. market is a “natural” fit for global expansion.

“The U.S. market is dynamic and rapidly expanding as demand for orthopedic implants grows in relation to the aging population,” said Son. “Corentec is well-positioned to meet this growing demand by introducing a range of novel solutions for Hip, Knee, and Spine in the coming decades. I see a great opportunity for Corentec America to make a significant mark … There are a number of attributes associated with our portfolio that differentiate our implants and instruments from our competitors.”

Corentec Co. Ltd. was founded in 2000.