L&K BIOMED CO., LTD. completed its application for additional approval with the FDA last month and received final approval on the 18th (local time), approximately one month after submitting the application.
The key aspect of this approval is the diversification of the base area where the cage contacts the vertebrae, while maintaining the height-expandable function of the previously approved product. The company expects this to broaden the range of product options available to medical professionals and support personalized treatment optimized for each patient’s anatomical characteristics.
The company pursued this approval based on clinical experience and feedback from U.S. healthcare professionals. It reflects the medical community’s input that a product lineup with diverse footprint sizes is necessary to respond more flexibly to patients’ anatomical structures and surgical conditions.
“BluEX-C” is designed to allow height adjustment starting at 4 mm upon insertion, up to a maximum of 15 mm. With this additional approval, users can now select not only the height but also the contact area with the vertebrae. The company expects that expanding the product specifications will facilitate hospital registration and product adoption in the U.S.
An L&K BIOMED CO., LTD. official stated, “The product’s competitiveness, which reflects the feedback from clinicians on the ground, is proving successful in the global market as well,” adding, “With the news of FDA approval, we are seeing an increase in inquiries and expressions of interest from major global companies, confirming the market’s high level of interest in the product.”
The spokesperson continued, “By adding these new sizes, we will address diverse clinical needs and further strengthen our product competitiveness,” adding, “We will actively expand local marketing and sales activities to drive tangible sales results and accelerate our push into the global cervical spine market.”
