Spineology wins FDA nod for Rampart One lumbar interbody fusion system

Spinal tech developer Spineology said this week it won FDA clearance for its Rampart One anterior lumbar interbody fusion system.
The St. Paul, Minn.-based company said the Rampart One is designed to minimize exposure and vascular retraction requirements associated with traditional anterior spine fusion procedure, and includes both standard and oblique interbody device footprints with integrated fixation screws.
“Variable angle instrumentation and integrated guides are colinear with the access, providing the surgeon the ability to keep the incision to a minimum,” Dr. Jeremy Shore said in a prepared statement.
“For instances where there is limited to no vessel mobility, the Rampart One oblique footprint is an excellent option,” Dr. Clifford Tribus said in prepared remarks.
The Rampart One is manufactured from the company’s Invibio Peek-Optima HA enhanced material, which Spineology claims provides an improved osteoconductive surface for bone in-growth, reduced stress shielding and artifact-free imaging.
“Minimizing exposure and retraction are cornerstone elements of all Spineology anatomy conserving designs. We are very excited about this approval and look forward to entering the anterior market in the near future,” CEO John Booth said in a press release.
In March, Spineology said it won expanded FDA clearance for its Elite expandable interbody fusion system designed for spinal fusion procedures. The company said it won cleraance for a...

Source: Mass Device - June 29, 2017 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance Spinal Spineology Source Type: news