CGBio Granted 510(k) for UniSpace TPLIF Cage

CGBio Medtech received FDA 510(k) clearance to market the UniSpace TPLIF Cage, designed for compatibility with the company’s NOVOSIS Putty bone graft substitute which received Investigational Device Exemption approval for clinical trials earlier this year.

UniSpace is inserted between vertebrae after removal of a damaged disc during the treatment of degenerative spinal diseases to enhance stability and support bone regrowth and fusion. The device utilizes titanium 3D printing technology to create a dual pore structure similar to human cancellous bone, and is available in a total of 256 specifications, allowing for customized application based on each patient’s anatomical conditions.

The internal space of the cage is designed to allow ample injection of bone substitute material, and the surface features a biomimetic porous pattern to promote bone cell growth. In particular, when used in conjunction with NOVOSIS, the structural optimization maximizes clinical efficacy.

Last year, CGBio Medtech received FDA clearance for the UniSpace Stand-Alone C Cage for cervical fusion, marking the company’s entry into the North American market. With this latest FDA clearance, the company has now completed its lineup of both cervical and lumbar cages.

NOVOSIS is currently distributed by Johnson & Johnson MedTech, and NOVOSIS PUTTY, having received FDA IDE approval, is set to begin full-scale clinical research in the United States.

Yoo Hyunseung, CEO of CGBio Medtech, stated, “This FDA clearance is a meaningful milestone that accelerates our entry into the U.S. market with an integrated treatment platform combining the technologies of CGBio Medtech and CGBio. By leveraging the technological capabilities and global networks of both companies, we aim to establish a new standard of care in the fields of spinal reconstruction and regenerative medicine.”

Source: The Asia Business Daily