L&K Biomed is accelerating its push into the U.S. spinal implant market by expanding the available sizes of its cervical expandable cage, BluEX-C.
L&K Biomed announced Aug. 20 that it received additional U.S. Food and Drug Administration (FDA) approval to expand the footprint sizes of BluEX-C. The footprint refers to the surface area of a spinal implant that directly contacts the vertebral bone.
The approval was pursued in response to requests from U.S. physicians. While retaining the implant’s existing height-adjustment function, the company diversified the contact area with the vertebral bone to allow physicians to select products based on each patient’s spinal anatomy and surgical circumstances.
BluEX-C is an implant inserted between vertebrae that can be expanded to adjust its height. It can be inserted at a height of 4 millimeters and expanded to up to 15 millimeters, allowing it to be adapted to a patient’s anatomical structure.
According to FDA data, the BluEX Cervical Expandable Cage System is classified as a cervical spinal fusion device. L&K Biomed also secured FDA 510(k) clearance for its existing product earlier this year.
The FDA’s medical device database lists BluEX-C products in various sizes, including 12×14 millimeters and 14×17 millimeters, as commercially distributed products. The expanded product line is expected to give physicians more options based on individual patients’ spinal anatomy.
BluEX-C is currently registered with 14 hospitals and customers in the U.S. and has already been used in actual surgeries. The company plans to expand the number of hospitals using the product and increase supply volumes to grow sales in the U.S. cervical implant market.
An L&K Biomed representative said, “The product competitiveness we’ve built by reflecting the needs of physicians in the field is gaining traction in global markets as well. With the addition of new sizes, we will expand our local marketing and sales efforts and translate them into tangible revenue growth.”