TDM secures self-certified GMP approval for 3D-printed patient-customized cheekbone implants, targets skull and spinal cage products next

TDM, a South Korean orthopedic and regenerative-medicine device maker led by CEO Kim Sun-mi, has obtained self-certified Good Manufacturing Practice approval for its patient-customized 3D-printed metal implants, starting with artificial cheekbones (zygomatic implants). The certification was built with support from Chonnam National University Hospital's Convergence Medical Device Industry Support Center under a bone-replacement device demonstration project. TDM's process reconstructs a patient's CT scan into a 3D model, then prints a metal implant matched to the exact geometry of the bone defect. The company plans to commercialize the cheekbone implant first, then extend the same manufacturing and quality-control framework to skull implants and spinal fusion cages.

Self-certified GMP is the manufacturing and quality-control prerequisite Korean device makers need before commercial sale domestically, and it typically precedes CE marking and FDA clearance for export markets. TDM was also named to the Ministry of SMEs and Startups' 2026 Jump-Up 100 program, which the company is using to formally launch its metal 3D printing and bio-medical device business line. With clinical collaborations at domestic hospitals in place, TDM said it will pursue CE and FDA approvals in stages to support entry into Asian and Middle Eastern markets. The cheekbone-to-skull-to-spine product sequence signals a craniomaxillofacial-first strategy before broader orthopedic expansion.