CG Bio, a Korean developer of spinal disorder and wound management solutions,  said on Monday its Advanced LumFix Spinal Fixation System (Advanced LumFix), an implant and surgical device for spinal correction, has received 510(k) clearance from the U.S. FDA.

With the approval, Advanced LumFix is expected to enter the U.S. spinal implant market quickly through CG Bio's U.S. subsidiary, CGMedTech, which was established in the first half of this year.

LumFix is a device for patients with spinal deformity that restores the original angle of the spine and stabilizes the spine to prevent further deformity. It was first launched in Korea in 2013 and rebranded as Advanced LumFix in 2020 with the addition of surgical instruments for enhanced patient and physician convenience. 

Advanced LumFix is the only spinal implant product in Korea that comes with a surgical instrument for spinal correction and has been actively recognized for its safety and efficacy, the company said.

It is indicated for use in spinal fusion for correction of spinal deformity and treatment of spinal lesions. When the spine is damaged or deformed due to degenerative diseases or accidents, drug treatment, and conservative treatment are first performed, but if symptoms of spinal damage persist, spinal fusion is performed to connect the upper and lower vertebrae. It can also be used to correct curvature of the spine such as scoliosis.

In particular, the product includes an additional hook that can be used in areas where it is difficult to place screws in a conventional lumbar laminoplasty configuration, or as a support for screws. It also includes nine additional connectors that provide strong fixation and the LumFix Multi Deformity Reducer (MDR) can correct the angle of the spine.

"Advanced LumFix is a next-generation spinal correction surgical solution that has been fully validated in the domestic spinal implant market, and with this FDA approval, we are now able to enter the U.S. in earnest," said CG Bio CEO Yu Hyun-seung. "As herniated disc disease is increasing in the U.S. and around the world, we hope that it will become an effective alternative for these patients."

CG Bio is an affiliate of Daewoong Pharmaceutical.