[Edaily Reporter Kwon Oh Seok ] T&R Biofab Co., Ltd(246710)’s stock price is showing strength in early trading. Buying interest appears to be surging following news that the company’s “TnR CI (Cranial Implant),” a biodegradable cranial reconstruction implant manufactured using proprietary 3D printing technology, has finally received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

According to MP Doctor on the 3rd, T&R Biofab Co., Ltd’s stock was trading at 3,175 won as of 9:12 a.m., up 6.67% from the previous trading day.
Earlier that day, the company issued a press release stating, “This FDA 510(k) clearance means that, following a comprehensive review of the submitted data on biological safety, chemical property evaluations, non-clinical performance, and animal testing, the TnR CI has been proven to be substantially equivalent in terms of safety and performance to existing approved products currently sold in the U.S.”
The company explained that this approval has laid the groundwork for it to fully enter the U.S. medical device market, the world’s largest. TnR CI is a bone-conductive artificial scaffold used to repair burr holes, craniotomy incisions, and other skull defects resulting from neurosurgical procedures, as well as to reinforce or restore the bony contour of the skull.
It combines the biodegradable polymer polycaprolactone (PCL) with beta-tricalcium phosphate (β-TCP), which promotes bone regeneration, and is precisely manufactured via 3D printing into a porous structure with interconnected internal channels. This design provides an environment conducive to bone tissue growth and is engineered to degrade and be absorbed by the body over a specific period following implantation.
TnR CI has been supplied to approximately 80 hospitals in South Korea since 2021, with over 17,000 patient implants, allowing the company to accumulate clinical data and expertise.
A representative from T&R Biofab Co., Ltd stated, “Building on the U.S. patent obtained last May and this FDA approval, we will actively secure distribution and sales partners in the U.S. and accelerate our expansion into global markets, including Latin America, the Middle East, and Asia.”