Spinal USA, a wholly owned subsidiary of Precision Spine, has gained 510(k) clearance from the FDA for the Slimplicity Solo anterior cervical plate system.
Slimplicity Solo is designed for anterior cervical fixation to the cervical spine C2-C7 for indications including degenerative disc disease, trauma (including fractures), tumours, deformity (such as kyphosis or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis and spinal stenosis.
Precision Spine president Rich Dickerson said that Slimplicity Solo is the company’s third product launch in two years.
"This product will provide surgeons with an exciting new fixation system for the cervical spine, offering potential benefits over existing, traditional cervical plating systems," Dickerson said.
"We also believe this product will have application in the expanding same day surgery market segment."
The new anterior cervical plate system, which consists of one and two level plates and 4.5mm fixed and variable screws, is designed to accommodate a visual locking confirmation with a secure locking mechanism, and provides an ergonomic colour coded instrument set.
University of California, San Francisco, associate professor and board-certified neurosurgeon Dr Henry Aryan said 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," Dr Aryan said.
"The system design lends itself for use in women, in thinner patients, or adjacent to an existing construct."
Image: Slimplicity Solo Anterior Cervical Plate System. Photo: Courtesy of Business Wire.