Flowood, Mississippi-based Zavation Medical Products, LLC has received FDA 510(k) clearance for its VariSync™ Plate System and VariSync Spacer System, both part of its cervical spine portfolio.
510(k) for Zavation Cervical Spine Plate and Spacer Systems
1 min read Premium comments
Secondary#varisyncplatesystem#varisyncspacersystem#zavationmedical
VariSync is a “cervical intervertebral body fusion device” which was developed to be used both as an independent system or as an integral part of Zavation’s broader cervical spine portfolio.
As Zavation’s CEO Jeffrey Johnson told OTW, “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.”
To begin with, Zavation’s 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 “intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. (DDD being defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies).”
Further, the 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.
“Patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.” Additionally, 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.”
Zavation CEO Jeffrey Johnson added, “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.”
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.