FDA 510(k) clearance for the Mini-Max Minimally Invasive Access System, Precision Spine announces


Mini-Max Minimally Invasive Access System, which has received clearance from the US Food and Drug Administration (FDA), is intended to enable spine surgeons to perform minimally invasive procedures using a versatile access/fixation system that has been designed to achieve results using a minimally disruptive procedure that are the same as or better than those achieved using the gold standard, open procedures.

The Mini-Max System, according to the company was designed to offer beneficial features for spine surgeons such as: techniques that are familiar to the surgeon as to shorten the learning curve and reducing operative time, and hardware to facilitate greater direct visualisation of the spine and easier access to the contralateral side and levels above and below the target level.

The system does not require a screw tulip head to reduce assembly time. It is also a muscle sparing technique which is anticipated to quicken the patient’s recovery process and improve patient outcomes.

The Mini-Max System is intended for use with the company’s S-LOK Pedicle Screw System. 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 the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The S-LOK System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra) in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (fracture or dislocation), spinal stenosis, curvatures (iscoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis, and failed previous fusion.

Rich Dickerson, president of Precision Spine, stated: “We believe that the first phase launch of the Mini-Max Minimally Invasive Access System represents a significant advancement in minimally invasive approaches to spine surgery. We are planning to make the system available in two phases. Phase one, the base system, will enable pedicle screw-based tissue retraction and distraction for maximal access to the disc space. Phase two, 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. The advanced interbody device and additional products with designs that are optimised for use with the new system are in development now, and will further enhance the potential benefits of this new approach to minimally invasive spine surgery.”