Zavation’s Interbody System receives FDA nodAugust 5, 2019
Zavation has received 510(k) clearance from the US FDA to market the Ti3Z Interbody System (TLIF, T-PLIF, and PLIF).
The Ti3Z Interbody System is used as 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.
The lumbar interbody implants 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 (DDD) with up to Grade I spondylolisthesis.
The implants offer a variety of heights, widths and lengths as well as parallel and lordotic angled implants, to accommodate variations in patients’ anatomy.
There are five main configurations: ALIF, LLIF, TLIF, T-PLIF, and PLIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade Titanium (Ti6AL4V).
The internal body of the implants has a porous structure while the external edges of the implants have a solid, roughened surface designed to engage with the vertebral body endplates. Both porous and solid aspects of each implant are printed simultaneously.