FDA Clears Spinal Simplicity’s Supplemental Posterior Fixation System

Overland Park, Kan.-based Spinal Simplicity LLC, a spinal device company, has earned 510(k) clearance for the Minuteman system.

The Minuteman is a pre-packaged sterile supplemental posterior fixation system, and is designed to offer a minimally invasive alternative to traditional pedicle screws and other spinous process plates that are placed in open procedures for the treatment of degenerative disc disease, spondylolisthesis, tumors and/or trauma. The Minuteman can be placed using two minimally invasive approaches to the spine, posterior unilateral or lateral percutaneous (percLIF—percutaneous lateral interlaminar fusion).

The percLIF surgical approach and instrumentation provide a way of quickly and accurately placing the Minuteman between the spinous processes through a one-inch incision. This technique eliminates the lateral dissection of sensitive back muscles often associated with lumbar fusions while maintaining an adequate distance from the neural structures.

“One of the many potential benefits of the Minuteman system is the PercLIF surgical approach to the spine. Direct lateral surgeons will now have the ability to insert a supplemental posterior fixation device with the patient remaining in the lateral decubitous position, typically in about 10 to 15 minutes,” said Todd Moseley, co-founder of Spinal Simplicity. “As a team, Spinal Simplicity believes this flagship product will provide the foundation for further innovation in the minimally invasive spine market.”

The company anticipates commercial launch of the Minuteman system in the first quarter of 2015.