Newly formed VySpine™, LLC’s posterior cervical thoracic system has received FDA 510(k) clearance.
VySpine Gets FDA Clearance for Posterior Cervical Thoracic System
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#fda510kclearanceSecondary#vyspine#posteriorcervicalthoracicsystem
The Tallahassee, Florida company announced the clearance of the VySpan Posterior Cervical Thoracic (PCT) system on January 6, 2022. The agency cleared the device on December 10, 2021, after a two-month review.
The company stated that “various screw and hook options, multiple transition rods and revolutionary crosslink versatility…and a variety of implant options for the thoracic spine makes the system one of the most versatile on the market.” Company CEO and industry veteran, Tom McLeer, boldly predicted, “This is just the beginning of the exciting, innovative product launches scheduled for early 2022.”
Device Components
According to FDA clearance documents, the system is comprised of implant and instrument components. The implant consists of posterior attachment elements with a set screw and rod. The pedicle screw component is offered in both poly-axial and mono-axial configuration.
In addition to these components, there are also ancillary components such as hooks, connectors, cross-links, and lateral offset connectors.
The company stated the system offers an assortment of rod-to-rod and cross connectors, including a “novel” head-to-head double joint cross connector, as well as three- and four-point cross connectors for extraordinary versatility. The rod-to-rod connectors, according to the company, allows the system to connect with larger Ø5.5mm and Ø6.0mm rods and includes transition rods, which taper from Ø3.5mm to either Ø5.5mm or Ø6.0mm.
FDA Indications
Indications for the system, used to promote fusion of the cervical spine and the cervicothoracic (Cl-T3), are the following:
- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture/dislocation
- Revision of previous cervical spine surgery
- Tumors
FDA documents note the use of the mini polyaxial screws is limited to placement in the upper thoracic spine (TI-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
“First of Many”
McLeer added that this is the “first of many highly differentiated systems” being developed by the company. “Using new materials and creative surgeon input, we are building exceptional quality, flexibility, and pricing into all our products.”
The company received its FDA registration this past July and named McLeer as its CEO last August. McLeer’s history includes roles at Zimmer, Interpore Cross, Spinal Concepts (sold to Abbott), Pioneer Surgical (sold to RTI), and Alphatec.
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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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