Zavation Medical Products, LLC, an employee-owned medical device company in Flowood, Mississippi, has a new FDA 510(k) clearance for its pedicle screw system.
Zavation Medical Pedicle Screw System Cleared for Sale
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According to the FDA filing, the system is comprised of polyaxial pedicle screws, rods, and cross connectors. The system can be used for “single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.”
Intended Use
The system is intended to “provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).”
In addition, the system is also indicated for “pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.”
When used as anterior thoracic/lumbar screw fixation systems, the system is indicated for “degenerative disc disease, spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).”
The company said 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.
Company CEO Jeffrey Johnson said the system “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.”
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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.
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