CGBIO Wins FDA Nod for Easymade TI Patient-Specific Cranial Implant

CGBIO has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Easymade TI 3D-printed, patient-specific titanium cranial implant.

This marks the first case of a Korean company gaining 510(k) clearance for a patient-specific titanium implant meant for the U.S. market. CGBIO said the achievement is particularly notable in the field of patient-specific cranial and craniofacial reconstruction.

Easymade TI implants are designed based on individual CT data and intended for reconstruction of cranial and non-load-bearing craniofacial defects. The implant is manufactured using medical-grade titanium alloy and produced via laser powder bed fusion (LPBF), an advanced metal 3D printing technology.

Once U.S.-based clinicians provide patient CT images, a customized design is finished at CGBIO’s design center in Korea. The finished implant is delivered to U.S. hospitals within five days. After being sterilized at the hospital, the implant can be used in surgical procedures.

Demand for cranial and craniofacial reconstruction continues to rise in the U.S., driven by cases like trauma, tumor resection, and decompressive craniectomy. Simultaneously, interest in patient-specific reconstruction solutions tailored to individual anatomy increases.

“The FDA 510(k) clearance of EASYMADE TI is a meaningful achievement that demonstrates CGBIO’s global competitiveness in patient-specific reconstruction solutions,” said CGBIO CEO Hyunseung Yu. “We will use this milestone as a foundation to expand our customized cranial and craniofacial implant business in the U.S. and accelerate regulatory approvals and commercialization of our pipeline products.”

The company received FDA breakthrough device status for its Novosis putty, an advanced bone substitute material, in 2024.