New Option in $5 Billion Spinal Implant Market
N Spine, Inc., has received FDA clearance of its NFix II dynamic pedicle screw and rod system for stabilization of the lumbar spine as an adjunct to fusion. This product may help meet the need of the growing market adoption for dynamic rod systems. The FDA’s 510(k) summary (pdf) dated from December 13, 2006 states that the product is “substantially equivalent” to devices such as DePuy AcroMed’s Moss Miami or the Dynesys system from Centerpulse Spine-Tech. Still, the administration thinks it is likely that the device will be used outside of the proposed labeling in a way that could cause harm, so the device labeling must include this warning: “The safety and effectiveness of this device for use in the treatment of spinal stabilization without fusion have not been established.”
N Spine received a Series A round of angel investment in October 2005 then closed its Series B in September last year. More information about its new product can be found in this press release.
See also: Study Questions Lumbar Fusion Outcomes
February 13, 2007 Related topics: Product Approval & Certification, Orthopedic