Corentec Knee Replacement Receives FDA Approval

Artificial joint specialist company Korentec Co., Ltd. (CEO Bon-cheol Koo) announced on the 23rd that it has received approval from the U.S. Food and Drug Administration (FDA) for the UCR (Ultra Congruent & Cruciate Retaining) type, a new insert product in its EXULT Knee System line of knee artificial joint products.

The UCR type tibial insert that received FDA approval this time is expected to significantly expand the variety of surgical techniques and patient-tailored treatment options as it overcomes the limitations of the company's existing products and can be applied to both surgical methods in which surgeons resect or maintain the posterior cruciate ligament.

According to Korentec Co., Ltd. on the 23rd, the company’s existing UC type was a structure that was only suitable for surgeons removing the posterior cruciate ligament, and had limitations that made it unsuitable for the surgical techniques of surgeons trying to preserve the posterior cruciate ligament. Accordingly, Korentec has newly developed the UCR type that can be used by all surgeons who maintain or resect the posterior cruciate ligament to increase the flexibility of the surgical method.

Corentec Co., Ltd. expects that this product line expansion will strengthen its global competitiveness. With the development of this UCR type, Corentec's EXULT System will now have a total of four insert lineups: ▲CR (Cruciate Retaining) ▲PS (Posterior Stabilized) ▲CPS (Constrained PS) ▲UCR types, providing a wider range of choices depending on the patient's condition and the surgeon's surgical preference.

In addition, Korentec Co., Ltd. is expecting a rapid market response and high sales growth after its launch. The UCR type is expected to record sales of approximately $6.05 million this year after its full-scale launch in the US market in April 2025. Sales are expected to grow by more than 30% annually thereafter, reaching approximately $7.86 million in 2026 and over $10 million in 2027.

“UCR type products are innovative solutions that support various surgical approaches, and have once again proven Corentec’s technological prowess in the global knee joint replacement market,” said Bon-cheol Koo, CEO of Corentec. “We will continue to accelerate the development of patient-centered products and expansion into the U.S. market.”


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