[Edaily Reporter KIM JI-WAN ] Orthopedic implant company OSTEONIC Co., Ltd.(226400)has acquired a controlling stake in FoxEyes, a U.S.-based developer of spinal surgery robots. Following its line of spinal implants, the company is expanding its business scope to include surgical equipment that helps doctors place screws exactly where planned.

OSTEONIC Co., Ltd. announced on the 4th that it had secured a 51% stake in FoxEyes for approximately 3 billion won. The company plans to acquire additional new shares worth 4 billion won in 2027 and 3 billion won in 2028. The total planned investment, including follow-on investments, amounts to 10 billion won.

Headquartered in Plano, Texas, FoxEyes’ flagship product is the AI-based spinal surgery navigation robot “F1 VSR.” The “Orbitech Co., Ltd.” vision camera identifies the patient’s position, while the robot tracks the position of surgical instruments based on joint movements. The company explains that by dividing the roles of tracking the patient and the instruments, it has reduced the equipment setup and calibration procedures required by conventional infrared systems. The development team is led by Vice President Woo Dong-ki, who previously oversaw surgical robot research and development at CUREXO, INC.

FoxEyes evaluated the robot’s precision using cadavers and test equipment at Baylor Scott & White Hospital in Texas. All screws evaluated remained within the boundaries of the vertebral body, earning a “Grade A”—the highest rating—in the insertion accuracy assessment. The 3D error between the planned location and the actual insertion location was 1.52 mm. According to the test data provided by the company, the surgical preparation time was 10.6 minutes—18.2 minutes shorter than the previous average of 28.8 minutes.

FoxEyes has set the projected unit price at $850,000. This is approximately 29% lower than the price of existing large surgical robots ($1.2 million), which the company used as a benchmark. The company plans to target not only large hospitals but also small and medium-sized hospitals and U.S. ambulatory surgery centers (ASCs), which are sensitive to equipment acquisition costs.

FoxEyes aims to submit a 510(k) application for the F1 VSR to the U.S. Food and Drug Administration (FDA) in the fourth quarter of this year and obtain U.S. marketing approval in the second half of 2027. According to the FDA, the 510(k) process evaluates whether a device has the same intended use as a comparator device legally sold in the U.S. and is substantially equivalent to it in terms of safety and effectiveness.

Lee Dong-won, CEO of OSTEONIC Co., Ltd., stated, “While we are starting with robots for spinal surgery, we will secure the core technologies for medical robots and expand our business into the fields of cosmetic and fracture-treatment robots in the future.” He added, “It is highly significant that we have secured additional mid- to long-term growth momentum to complement our existing stable growth.”