Spinal hardware and biologics company Zavation said it has received FDA 510(k) clearance to market its Ti3Z interbody system, a lumbar intervertebral body fusion device.
The implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients who have had six months of non-operative treatment. They are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease with up to Grade I spondylolisthesis.
The Ti3Z interbody implants are made of titanium with a porous internal structure and solid, roughened external edges designed to engage with the vertebral body endplates. Both porous and solid aspects of each implant are printed simultaneously, according to Jackson, Miss.-based Zavation. The implants come in a variety of heights, widths and lengths as well as parallel and lordotic angled implants. They are available in five configurations (ALIF, LLIF, TLIF, T-PLIF, and PLIF) to allow for multiple surgical technique options.
“Our research and development team combined the best of both worlds,” said Zavation CEO Jeffrey Johnson in a news release. “The interior lattice structure promotes osseointegration and optimal elasticity, while the external edges of the implant maintain mechanical stability.”
Zavation will showcase the Ti3Z interbody system at the North American Spine Society annual meeting in Chicago, September 25-27, 2019.