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FDA Approves Precision Spine's Mini-Max

Manufacturing Group | December 13, 2012

The Minimally Invasive Access System Achieves Results Using Minimally Disruptive Procedure

Precision Spine has received 510(k) clearance from the FDA for its Mini-Max Minimally Invasive Access System.

The addition of the Mini-Max Minimally Invasive Access System to the company’s expanding array of minimally invasive spinal solutions will 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 new system has been designed to offer several distinguishing features and benefits as compared with currently available minimally invasive surgery (MIS) systems. It uses techniques that are familiar to surgeons, potentially shortening any learning curve and reducing operative time. Its hardware and corresponding procedural steps are configured to facilitate greater direct visualization of the spine and easier access to the contralateral side and levels above and below the target level. In eliminating the need to remove the screw tulip head during assembly, the design team sought to reduce “fiddle factor” as well as the overall number of procedural steps. The system’s muscle sparing technique, contrasted with percutaneous approaches that puncture muscle, is anticipated to speed recovery time and improve patient outcomes. The design team focused on enabling more easily achieved procedure-to-procedure reproducibility, with the goal of enhancing cost-effectiveness for hospitals and payers.

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 immobilization and stabilization 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 (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis, and failed previous fusion.

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