FDA expands indication for Titan Spine's Endoskeleton
This article was originally published in Clinica
The US FDA has expanded the labelling of Titan Spine's Endoskeleton to include its use as an interbody fusion device. Its previous 510(k) clearance in September 2003 covered its use for vertebral body replacement. Mequon, Wisconsin-based Titan explained that the device was previously used to replace bone, but can now also replace spinal discs. The new indication is for skeletally-mature patients with degenerative disc disease at one or two contiguous levels from the second lumbar to the first sacral vertebra, who have already received six months of non-operative treatment. Titan hopes the expanded indication will increase adoption of the product, and estimates that 65 million people in the US have some type of degenerative disc condition.