Precision Spine, Inc. has announced that its wholly owned subsidiary, Spinal USA, Inc., has received 510(k) clearance from the FDA for the Slimplicity® Solo Anterior Cervical Plate System, adding another important cervical product to the broad and expanding Spinal USA product portfolio.
According to a press release, the new onomatopoeically named Slimplicity Solo anterior cervical plate system does exactly what it says on the tin by offering one of the slimmest profile plates available in the market. It is designed to have a simple and secure locking mechanism that accommodates visual locking confirmation. The system is comprised of one and two level plates and 4.5mm fixed and variable screws, and provides an ergonomic color coded instrument set.
The system is intended for anterior cervical 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 hours we’ve devoted to product research and development is producing great results,” stated Rich Dickerson, President of Precision Spine. “With Slimplicity Solo, we have our 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. We also believe this product will have application in the expanding same day surgery market segment.”
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.”
Source: Precision Spine and Spinal USA