CGBIO wins FDA 510(k)

CGBIO Receives FDA 510(k) Clearance for Patient-Specific Titanium Implant ‘EASYMADE TI’

April 24, 2026
10:09 pm

SEOUL, South Korea, April 24, 2026 /PRNewswire/ -- CGBIO (CEO: Hyunseung Yu) announced that its patient-specific titanium implant, EASYMADE TI, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on April 9. The FDA 510(k) pathway is a premarket clearance process that demonstrates substantial equivalence to a legally marketed predicate device, allowing commercialization in the United States.

This milestone marks the first case of a Korean company obtaining FDA 510(k) clearance for a patient-specific titanium implant intended for the U.S. market. It highlights CGBIO’s technological capabilities as well as its regulatory expertise in global markets. The achievement is particularly notable in the field of patient-specific cranial and craniofacial reconstruction.

EASYMADE TI is a patient-specific titanium implant 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 through Laser Powder Bed Fusion (LPBF), an advanced metal 3D printing technology.

CGBIO Receives FDA 510(k) Clearance for Patient-Specific Titanium Implant ‘EASYMADE TI’

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