Spinal tech developer Spineology said today it won expanded FDA clearance for its Elite expandable interbody fusion system designed for spinal fusion procedures.
The Minneapolis, Minn.-based company said it won clerance for a narrower 10mm version of the device, as well as an extended indication allowing the device to be used with allograft bone.
“The broader size offering and the allograft bone indication allow the surgeon to pair Elite with Incite cortical fibers. Incite’s excellent handling properties and ability to expand in-situ with the Elite implant are added benefits not found in competitive systems,” CEO John Booth said in a prepared statement.
The Elite expandable interbody fusion implant is designed to be inserted into the disc space at a contracted minimum height and expanded once in position to restore anatomic disc height, provide better anterior column support and potentially allow for indirect decompression, the company said.
“The Elite expandable interbody device is an ideal choice when treating patients with a minimally invasive approach. The minimal initial starting height and a 10mm wide footprint reduces neural retraction requirements. Additionally, having the Incite bone graft that expands with the implant helps ensure good graft apposition,” Dr. Mark Grubb of Cleveland, Ohio said in prepared remarks.
Last October, Spineology said it won FDA 510(k) clearance for its Rampart Duo interbody fusion system. The company said its newly-cleared Rampart Duo is the 1st device of its kind to combine PEEK, titanium and graft containment mesh elements.
The Rampart Duo is designed to include PEEK spacer blocks position at each end of the device with a flexible porous graft containment mesh to create a central graft cavity. The mesh is designed to be filled with bone craft material in order to deploy the device in the anterior-posterior direction, Spineology said.