Vertera Spine said yesterday it won FDA 510(k) clearance for its porous PEEK Cohere cervical interbody fusion device.

The Cohere device is composed entirely of Vertera Spine’s novel PEEK Scoria porous biomaterial which the company said is more durable than metal coatings and 2 times stronger under shear loading than trabecular bone.

“The FDA clearance of Cohere represents a significant milestone for Vertera Spine and fusion devices in spine. Given the new economics of healthcare, market demands are shifting towards more effective implant technologies at a better price. Cohere, featuring surface porous PEEK Scoria, will be the first in a new generation of biomedical implant innovations to meet this demand,” CEO Chris Lee said in a press release.

Scoria is designed to facilitate bone tissue in-growth, featuring a fully interconnected pore network with a wettable surface, which Vertera says bone is able to “infiltrate” and form direct contact with.

“Surgeons have been seeking an all Peek fusion solution that leads to direct bone apposition instead of fibrous encapsulation. Cohere is a game-changing device for spine fusion.  By leveraging the performance of the Scoria technology, Vertera Spine will be able to generate a portfolio of implant solutions that were previously not possible,” board director Tim Nash said in prepared remarks.

Vertera Spine will commercially launch Cohere in multiple configurations some time in 2016, the company said.