L&K Biomed Receives US FDA Approval for SAI Screws

Expansion of Sterile Lineup for Spinal Pedicle Screws

[Asia Economy Reporter Hyungsoo Park] L&K Biomed announced on the 22nd that it has received product approval from the U.S. Food and Drug Administration (FDA) for implants used in Sacral-Alar-Iliac Screw Fixation (SAI screw fixation).

SAI screw fixation is one of the advanced surgical methods that is not yet widely known in Korea. Unstable pelvic ring injuries caused by high-energy trauma have a high possibility of accompanying injuries to limb joints and multiple organs. Surgical treatment is generally required to reduce complications related to prolonged bed rest.

Regarding unstable pelvic ring injuries, sacro-iliac screw fixation using sacroiliac screws or spino-pelvic fixation using iliac screws are the most widely used methods. Although these are common methods, surgical procedures are not easy for various reasons, and complications including procedural errors are not uncommon.

Recently, SAI screw fixation has been used as a limited alternative. Since the SAI screw must be fixed sufficiently long within the ilium by passing through the sacroiliac joint from the posterior cortical bone of the second sacral vertebra, the angle between the screw head and the part inserted into the bone is large, making manufacturing difficult.

L&K Biomed newly launched the ‘Accelfix-S’ in 2018, which has a smaller screw head than conventional pedicle screws. Through continuous research and development, the company succeeded in developing an SAI screw with a small head that can be used for SAI screw fixation. With product approval, sales in the U.S. have also become possible.

With FDA approval, L&K Biomed can supply SAI screws along with pedicle screws used for lumbar and thoracic vertebrae. The SAI screws will also be sold as sterile products.

A company representative stated, "We will complete the entire product lineup related to the spine and continuously develop world-class products in terms of quality and safety," adding, "Once customers use L&K Biomed products, they will inevitably continue to use them, creating a captive market."