Vertera Spine Receives FDA 510(k) for COALESCE PEEK LIF Device

By Julie A. Vetalice

Vertera Spine received FDA 510(k) clearance to market the COALESCE™ interbody fusion device for anterior, transforaminal, posterior and lateral lumbar interbody fusion. Initially, TLIF and PLIF versions in multiple sizes will launch later in 2017.

The PEEK-based implants feature porous architecture on select faces, which is derived directly from the implant and is not sintered or added as a coating. The material is reportedly more durable than metal coatings and two times stronger under shear loading than trabecular bone, and was also used on Vertera's COHERE® cervical device.

Sources: Vertera Spine; ORTHOWORLD Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory