Orthopedic implant specialist CG MedTech announced on Monday that its spinal fixation device, the INNOVERSE Spinal System, has been successfully used in surgeries at U.S. hospitals.
The INNOVERSE system received FDA 510(k) clearance in February 2024, a crucial regulatory step required for marketing medical devices in the United States.
Notably, CG MedTech became the first Korean manufacturer to demonstrate compatibility with Medtronic’s StealthStation™, an advanced spinal surgery navigation system, as part of the FDA approval process.
Following its official launch in the U.S. market in March 2025, the first surgery using the INNOVERSE system was successfully performed at Memorial Hermann Surgical Hospital in Texas. The procedure was conducted under the supervision of Dr. Steven J. Cyr, a specialist in orthopedic and reconstructive surgery.
The INNOVERSE system’s core innovation lies in its dual-thread design featuring cortical and cancellous screw threads. This technology accommodates the differing densities of cortical and cancellous bone, enabling precise engagement with the hard cortical bone and secure fixation in the softer cancellous bone. This design helps reduce operation time and improves stability at the surgical site.
CG MedTech CEO Yoo Hyun Seung stated that the INNOVERSE represents an integrated spinal surgery solution that combines the company’s technological capabilities and clinical expertise. He added that the company plans to sequentially supply the system to major North American hospitals, accelerating its expansion into the global market.