Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera® X Lateral Interbody Fusion System.
Tesera X is the latest product to utilize Renovis’ proprietary 3D-printed porous architecture, which is made using additively manufactured titanium alloy, and features a low modulus, load-sharing design with a randomized pore structure to mimic cancellous bone. A 550-micron average pore size and 68% porosity combined with micro-surface roughness within the structure makes for an ideal environment for bone ongrowth and ingrowth.
Tesera X completes Renovis’ 3D-printed titanium interbody product portfolio, which also includes implants for ALIF, TLIF, PLIF, ACDF, and standalones. The company is hoping to take advantage of the recent consolidations in the spine market.