The US Food and Drug Administration (FDA) has granted 510(k) approval to Precision Spine’s minimally invasive spinal fixation system for use with the company’s S-LOK pedicle screw system.
Using minimally disruptive techniques, the Mini-Max minimally invasive access system shortens any learning curve and reduces operative time.
In addition, the configured hardware and corresponding procedural steps of the system facilitates direct visualisation of the spine and easier access to the contralateral side and levels above and below the target level.
The ‘fiddle factor’ as well as the overall number of procedural steps were also reduced to eliminate the need of removing the screw tulip head during assembly, according to the company.
Minimally Invasive Spine Surgery Institute director and new system lead development surgeon Dr Donald Kucharzyk said; "The development of this system was driven by our desire to make available to spine surgeons an MIS system that results in less surgical trauma to the patient, utilizing known muscle sparing techniques with resultant better patient recovery and outcomes."
Precision Spine president Rich Dickerson said the company is planning to make the system available in two phases including Phase I, the base system, which will enable pedicle screw-based tissue retraction and distraction for maximal access to the disc space.
"Phase II, the additional system components, will enable parallel, bilateral distraction of vertebral bodies to facilitate even more effective placement of an advanced interbody device, which is now in the development phase," Dickerson said.
"The advanced interbody device and additional products with designs that are optimized for use with the new system are in development now, and will further enhance the potential benefits of this new approach to MIS spine surgery."
The S-LOK system is intended to provide immobilisation and stabilisation of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative spondylolisthesis, trauma, spinal stenosis, curvatures, spinal tumor, pseudarthrosis and failed previous fusion.