Renovis Surgical Gains FDA Clearance for New Tesera ALIF System

By Julie A. Vetalice

Renovis Surgical Technologies received FDA 510(k) clearance to market Tesera® SA Hyperlordotic ALIF, a standalone interbody fusion system.

Like the rest of the company's Tesera implants, SA-HL is made using additive manufacturing to create a roughened, highly porous surface to support bone attachment and ingrowth. A four-screw design and locking cover plate are intended to prevent screw backout.

Other 3D-printed, porous titanium systems from Renovis address anterior cervical, anterior lumbar and posterior lumbar fusion.

Source: Renovis Surgical

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory