Spinal Simplicity has received its third 510(k) clearance from the US Food and Drug Administration (FDA) for the Minuteman G3-R spinal implant, part of the Minuteman family of supplemental fusion and fixation devices. The Minuteman G3-R is intended to be implanted via a minimally invasive lateral approach and will have a lower profile upon placement of the device.
“The lower profile of the Minuteman G3-R provides an aesthetic enhancement while maintaining the key elements of strength of the device and its minimally invasive nature,” says Todd Moseley, co-founder and chief executive officer of Spinal Simplicity.
The Minuteman G3-R is a sterile packed, posterior, non-pedicle supplemental fusion and fixation device for use in the non-cervical spine (T1-S1). As an alternative to traditional pedicle screws, it is a plating system intended for supplemental fusion in patients with degenerative disc disease, spondylolisthesis, trauma and tumour. The device is available in the USA with hydroxyapatite coating and a removable 12mm portion of the implant body. The Minuteman is intended for use with bone graft material and is not intended for stand-alone use.