Zavation’s Cervical Intervertebral Body Fusion Device Cleared by FDA

The FDA has granted 510K Clearance of Zavation Medical Products’ Varisync, a cervical intervertebral body fusion device.
 
Varisync, the most recent addition to the Zavation cervical spine portfolio, has been tested and approved for both the independent and synchronized use of its plate and spacer components. This allows Zavation’s surgeon partners to use these plate and spacer options together as a system or pair individual components with any of Zavation’s existing cervical portfolio options.
 
The Varisync plate has been thoughtfully designed and boasts attributes that include visual and tactile confirmation of locks, ideal screw angulation, multiple insertion devices, and optimal spacer placement in the disc space.
 
“Our product development team’s dedication to creatively blending simplicity and precision in a robust product design has produced a product that we believe is the new gold standard in facilitating patient fusion in a seamless and simplified procedure,” said Jeffrey Johnson, chief executive officer “With the extensive interbody offerings that Zavation boasts, it only makes sense that we develop a device, that allows surgeons to easily integrate and place a plate and spacer combination of their choice.” This product is an example of Zavation’s commitment to offering innovative and differentiated products in conjunction with market leading customer service to best serve our surgeons and distributor network.”

Indications for Use

The VariSync Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
 
The VariSync Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
 
The VariSync Spacer is to be filled with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. These devices are intended to be used with supplemental fixation such as the Zavation VariSync Plate, Zavation Midline Plate, Zavation EZ Plate, or Zavation Cervical Plate Systems. When used with the VariSync Plate, the assembly takes on the indications of the VariSync Spacer, with the VariSync Plate acting as the supplemental fixation.