Therapy Areas: Devices
Zavation awarded US FDA clearance for the Ti3Z Interbody System (TLIF, T-PLIF, and PLIF) body fusion implant device
5 June 2019 -

Medical device company Zavation on Tuesday announced the US Food and Drug Administration (FDA) 510(k) market clearance for the Ti3Z Interbody System (TLIF, T-PLIF and PLIF) for use as a lumbar intervertebral body fusion implant device with immediate effect.

The company added that the Ti3Z Interbody System 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.

In conjunction, the Zavation Ti3Z Interbody implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System, for all the indications.

According to the company, the Zavation Ti3Z Interbody implant is available in different configurations 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.

Additionally, the company will present the Ti3Z Interbody System at the North American Spine Society (NASS) annual meeting in Chicago, IL from 25-27 September 2019.