Sijibio's Spinal Implant 'Advanced Lumpix' Receives FDA 510k Clearance

Published 14 Aug.2023 10:04(KST)

Bio regenerative medicine specialist CJ BIO announced on the 14th that its Advanced LumFix Spinal Fixation System, an implant and surgical instrument for spinal correction, has received premarket approval (510k) certification from the U.S. Food and Drug Administration (FDA).

CJ BIO's spinal correction implant and surgical instrument 'Advanced LUMPICS Spinal Fixation System' <br>[Photo by CJ BIO]

CJ BIO's spinal correction implant and surgical instrument 'Advanced LUMPICS Spinal Fixation System'
[Photo by CJ BIO]

The approval of the Advanced LumFix was achieved about one year after the application was submitted in July last year. The company expects to rapidly enter the U.S. spinal implant market through its U.S. subsidiary CGMedTech, established in the first half of this year.

LumFix is a device designed to restore the original angle of the spine and fix it to prevent further deformation in patients with spinal deformities. First launched domestically in 2013, it was re-released under the name Advanced LumFix in 2020 with additional surgical instruments that enhance convenience for patients and medical staff. Advanced LumFix is the only domestic spinal implant product equipped with surgical instruments specifically for spinal correction.

Advanced LumFix has been approved for use in spinal fusion surgery aimed at "correcting spinal deformities" and "treating spinal lesions." When the spine is damaged or deformed due to degenerative diseases, accidents, or other reasons, drug therapy and conservative treatments are initially applied. If symptoms persist or do not improve, spinal fusion surgery, which joins the vertebrae above and below, is performed. It can also be used to correct conditions such as scoliosis, where the spine curves beyond the normal range.

Notably, Advanced LumFix includes an additional "Hook" that can be applied to areas where screws are difficult to insert or where screw fixation strength is insufficient, serving as support for the screws. The hook’s angle can be adjusted, allowing customized application to different spinal shapes for each patient. Advanced LumFix is the only spinal correction implant product in Korea with an adjustable-angle hook.

Yoo Hyun-seung, CEO of CJ BIO, stated, “Advanced LumFix is a next-generation spinal correction surgical solution that has been sufficiently validated in the domestic spinal implant market, and with this FDA approval, we can now officially enter the U.S. market. As degenerative disc diseases are increasing worldwide, we hope Advanced LumFix will become a new and effective alternative for disc patients.”