L&K Biomed Applies for FDA Approval of Height-Expandable Cage

Spinal implant specialist L&K Biomed announced on the 20th that it has completed the application for approval from the U.S. Food and Drug Administration (FDA) for six new height-expandable cage products in the ‘BlueX Series.’

The six ‘BlueX Series’ products for which L&K Biomed is seeking FDA approval are height-expandable cages designed for lumbar (lower back) use, developed as a lineup that covers various surgical methods: ▲BlueX-T (height-expandable cage for posterior thoracic surgery) ▲BlueX-TC (height-expandable cage for posterior thoracic endoscopic surgery) ▲BlueX-L and BlueX-LT (height-expandable cages for lateral surgery) ▲BlueX-ATP (height-expandable cage for lateral/anterolateral use) ▲BlueX-A (height-expandable cage for anterior abdominal surgery).

The new product line features a roughened surface treatment to promote faster and stronger bone fusion between the titanium height-expandable cage and the patient’s spinal bone.

L&K Biomed developed the BlueX-TC as a product equipped with a cannula suitable for percutaneous surgery, enabling minimally invasive and endoscopic surgery using a guide wire during the process of inserting the cage into the disc.

Since the FDA approval process typically takes about three to five months from application to approval, the results of the BlueX Series approval application are expected to be known within the first quarter of next year. Following FDA approval, the BlueX Series is anticipated to strengthen competitiveness through a more diverse product lineup.

An L&K Biomed representative stated, "While developing the six BlueX Series products, we upgraded existing products and further segmented them, advancing as a specialized spinal expandable device company. We will continue to make various efforts to protect patients’ healthy lives by developing multiple expandable innovative products, including BlueX."

They added, "The U.S. spinal implant market is approximately 9 trillion KRW in size, accounting for about 70% of the global spinal implant market. Since height-expandable cages are becoming the mainstream over traditional fixed cages in the U.S., we expect the growth of the new height-expandable cage product line, BlueX, to accelerate."