CG MedTech, a leading orthopedic and dental implant company, has secured approval for its spinal fixation system in Colombia, paving the way for expansion into the Latin American market.
The company announced on Wednesday that its INNOVERSE Spinal System received Class IIb medical device approval from Colombia’s National Food and Drug Surveillance Institute (INVIMA) on September 30.
This regulatory milestone enables CG MedTech to distribute its products in Colombia. The firm plans to partner with local distributor IMPLAMEQ to drive product sales.
The INNOVERSE Spinal System is a cutting-edge posterior spinal fixation device designed to stabilize and secure spinal segments in the thoracic, lumbar, and sacral regions. It’s indicated for surgeries addressing conditions such as spondylolisthesis, trauma-induced fractures and dislocations, spinal stenosis, spinal deformities, pseudarthrosis, and failed previous spinal fusion procedures.
The system’s screws feature an innovative dual-thread design with varying thread patterns. Available in both integrated and modular configurations, the company currently manufactures and markets the integrated version.
CG MedTech is actively expanding its regulatory footprint in the U.S. and Latin America. Following the U.S. Food and Drug Administration (FDA) 510(k) clearance for the INNOVERSE Spinal System in February 2024, the company secured additional approvals in Guatemala, Peru, and Ecuador that same year.
The Colombian approval marks another significant milestone in CG MedTech’s Latin American market strategy. The company is gearing up for product rollout with IMPLAMEQ while planning comprehensive training sessions and academic initiatives for local healthcare professionals.
A spokesperson for CG MedTech emphasized that securing regulatory approval is just the first step. The focus now is on establishing a robust supply chain and educating medical professionals to ensure seamless integration of the products into clinical practice. It’s committed to addressing the needs of Colombian surgeons and building a sustainable, long-term presence in the Latin American market.
CG MedTech traces its roots to U&I, founded in 1997 to manufacture and distribute orthopedic body correction devices. The company went public on the KOSDAQ in 2015, underwent name changes to Edisoninno and Innosys in 2022, before rebranding as CG MedTech in 2024. While spearheading its global expansion in spinal implants, the firm is also diversifying its portfolio to include dental implants, positioning itself for sustained growth in the medical device sector.