Renovis Surgical Technologies said today that it won 510(k) clearance from the FDA for its Tesera SA hyperlordotic ALIF interbody spinal fusion system.
The company’s porous, titanium, stand-alone anterior lumbar interbody fusion system features a four-screw design and a locking cover plate designed to prevent screw backout.
Renovis’ Tesera implants are made using additive manufacturing, according to the company, and include a porous surface structure to enable bone attachment and in-growth to the implant.
With its latest regulatory win, Renovis’ portfolio of 3D-printed titanium implant systems include anterior cervical, anterior lumbar and posterior lumbar devices.
