Orthopedic implant research and manufacturing specialist CG MedTech said on the 7th that its spinal fusion device "UniSpace (UniSpace® TPLIF Cage, lumbar cage)" has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA). CG MedTech is a subsidiary of CGBio, an affiliate of the Daewoong Pharmaceutical group.
The newly cleared lumbar "UniSpace" is a spinal implant structure (cage) that is inserted between vertebrae after the damaged disc is removed in the treatment of degenerative spinal disease to increase stability and help bone regrow and fuse.
By applying titanium 3D printing technology, it implements a dual pore structure similar to human cancellous bone. Comprising a total of 256 specifications, it can be customized to a patient's anatomical conditions. The internal space of the cage is designed wide enough to allow ample injection of bone substitutes. A biomimetic porous surface pattern is applied to promote bone growth (bone ingrowth, bone ongrowth) as bone cells grow and attach.
It is a device designed for use with CGBio's next-generation bone substitute "NOVOSIS PUTTY." NOVOSIS PUTTY received Investigational Device Exemption (IDE) approval from the U.S. FDA in April for product approval and has begun clinical trials. CG MedTech obtained FDA clearance last year for the cervical fusion "UniSpace® Stand-Alone C Cage (cervical cage)," accelerating its full-fledged entry into the North American market.
The company said this FDA clearance is meaningful in that it completes both the cervical and lumbar cage lineups.
Yu Hyun-seung, CEO of CG MedTech, said, "This FDA clearance is a meaningful achievement that accelerates entry into the U.S. market with the integrated treatment platform of CG MedTech and CGBio," adding, "We will combine the two companies' technological strengths and global networks to create a new standard of care in spinal reconstruction and regenerative medicine."