S.Korea's CGBio gets FDA approval for spinal implant

CGBio, a South Korean bio-regenerative medical company, announced on Monday that its "Advanced LumFix spinal fixation system," an implant and surgical device for spinal correction, has received 510k clearance from the US Food and Drug Administration (FDA).

The 510k clearance indicates that the medical device has demonstrated equivalence to existing equipment in terms of its intended use and performance testing, making it safe for commercial use.

The LumFix system is designed to restore the original angle of the spine and immobilize it to prevent further aggravation, targeting patients with spinal deformities. Originally launched in 2013 in South Korea, the system was rebranded as the "Advanced LumFix" in 2020 after the addition of surgical instruments.

The FDA clearance allows the Advanced LumFix system to be used for spinal fusion surgery aimed at "correcting spinal deformities" and "treating spinal disorders." While non-surgical treatments such as medication and preservation therapy are typically attempted first for spinal injuries or deformities caused by degenerative diseases or accidents, spinal fusion surgery, which involves connecting the vertebrae above and below, is performed when other treatments are ineffective.

"As a next-generation surgical solution for spinal correction that has been well validated in the domestic spinal implant market, this FDA clearance opens the door for our entry into the US," CEO of CGBio Yu Hyun-Seung remarked.

Write to Jeong Min Nam at peux@hankyung.com