Spinal Simplicity was granted FDA 510(k) clearance of a new Indication for Use for its Minuteman family of implants: Lumbar Spinal Stenosis. This addition to the existing FDA-cleared indications of degenerative disc disease, spondylolisthesis, trauma and tumor allows Spinal Simplicity to identify and treat a new patient population using the Minuteman device.
The Minuteman is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1).
The Minuteman is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (T1-S1).
Source: Spinal Simplicity