Spinal USA (Pearl, MS) has announced that its Slimplicity Solo anterior cervical plate system has been cleared via FDA’s 510(k) pathway, making it the third product that the company has introduced in the last two years. In 2011, the company debuted the Vault ALIF System and the Sure Lok Mini Posterior Cervical/Upper Thoracic System.
The Simplicity Solo device was designed for fixation of the C2–C7 vertebrae to manage trauma, degenerative disc disease, deformity, pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
The manufacturer describes the titanium device, which comes with 4.5-mm fixed and variable screws, as “one of the slimmest profile plates available in the market.”
From the press release:
After evaluating the new system, Dr. Henry E. Aryan, a board certified neurosurgeon and Associate Professor at the University of California, San Francisco (“UCSF”), commented, “The Slimplicity Solo is well designed for use in 1- and 2-level ACDFs. Its narrow footprint and low profile are dimensioned to reduce strap muscle dissection and dysphagia. Its single, larger diameter screw-plate construct enables stability and facilitates quicker implantation. The system design lends itself for use in women, in thinner patients, or adjacent to an existing construct.”