[Edaily Reporter NA EUN-KYUNG ] CG MedTech ( Innosys(056090)), a company specializing in orthopedic and dental implants, announced on the 7th that its spinal fixation system, the “INNOVERSE Spinal System,” has received medical device approval from the Colombian Institute for Food and Medicines (INVIMA). CG MedTech is a KOSDAQ-listed company whose largest shareholder is CG Bio, a spin-off from DAEWOONGPHARMACEUTICAL(069620).

The approval date was the 30th of last month, and the product is classified as Class IIb. Based on this approval, CG MedTech plans to work with its local partner, IMPLAMEQ, to supply the product throughout Colombia. IMPLAMEQ is an orthopedic medical device company that has been operating in Colombia for over 17 years. It handles products for spinal surgery, trauma, joint replacement, and external fixation, and operates distribution hubs in major cities across the country.

The Inovus Spinal System is a posterior spinal fixation system designed to stabilize and fixate spinal segments in the thoracic, lumbar, and sacral regions. It is used in surgeries for conditions such as spondylolisthesis, trauma-related fractures and dislocations, spinal stenosis, spinal deformities, pseudoarthrosis, and cases of failed previous spinal fusion.

The product’s screws feature a dual-thread structure with different thread profiles. The system consists of a monoblock design, in which the screw and head are integrated, and a modular design, where the two components can be assembled separately; both types were included in this Colombian approval. The company is currently manufacturing and selling the monoblock product.

The Inovus Spinal System previously received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in February 2024. According to FDA documents, the system underwent the approval process as a Thoracolumbosacral Pedicle Screw System and was determined on February 6, 2024, to be substantially equivalent to an existing approved device. In the United States, it is classified as a Class II medical device.

CG MedTech also secured approvals for the Inovus Spinal System in Guatemala, Peru, and Ecuador that same year. The Inovus Spinal System is currently being used in actual surgeries at U.S. hospitals. With this latest approval in Colombia, the company explains that it is expanding the list of countries where the product can be sold in Central and South America, following its entry into North America.

CG MedTech plans to prepare for product supply in collaboration with its local partner, IMPLAMEQ, while also conducting product training and academic activities for Colombian medical professionals. The company also intends to expand the supply of spinal implants in countries where it already holds approvals in Latin America by collaborating with distribution partners.

Yoo Hyun-seung, CEO of CG MedTech, stated, “After securing regulatory approval, it is crucial to establish a foundation for practical use through stable product supply and training for medical professionals.” He added, “We will work with our local partner to meet the demand in the Colombian market and expand our supply and training systems throughout Latin America.”