Zavation Gains FDA Clearance for the Ti3Z Interbody System

 Zavation, an employee-owned medical device company that designs, develops, manufactures and distributes medical device products, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Ti3Z Interbody System (TLIF, T-PLIF, and PLIF). The company will commence launching Ti3Z Interbody system immediately to the U.S. market.
 
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 lumbar device is intended to be used in patients who have had six months of non-operative treatment. For all the above indications the Zavation Ti3Z Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System.
 
The Zavation Ti3Z Interbody implants offers 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 have a porous structure while the external edges of the implants have a solid, roughened surface designed to engage with the vertebral body end plates. Both porous and solid aspects of each implant are printed simultaneously.
 
CEO Jeffrey Johnson stated, “Our research and development team combined the best of both worlds. The interior lattice structure promotes osseointegration and optimal elasticity, while the external edges of the implant maintains mechanical stability.”
 
Based in Flowood, Miss., Zavation designs, develops, manufactures, and distributes spinal medical device products that provide comprehensive medical solutions to help surgeons treat patients around the world.