FDA approves minimally invasive spine solution

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

According to a press release, the Mini-Max Minimally Invasive Access System will enable spine surgeons to perform minimally invasive surgery (MIS) with a versatile “access/fixation” system that uses a minimally disruptive procedure. Designed to offer several distinguishing features and benefits, it uses techniques that are familiar to surgeons, potentially shortening any learning curve and reducing operative time. Its hardware is configured to better visualize the spine and ease access to the contralateral side as well as levels above and below the target level.

“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,” Rich Dickerson, president of Precision Spine, stated in a press release.

Dickerson said the system will be available in two phases: a base system which will enable pedicle screw-based tissue retraction and distraction for access to the disc space, while a second phase in development will enable parallel bilateral distraction of vertebral bodies to facilitate placement of an interbody device.

“The advanced interbody device and additional products with designs that are optimized for use with the new system are in development now, and will further enhance the potential benefits of this new approach to MIS spine surgery,” Dickerson said.