Renovis Surgical Technologies has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Tesera SA Hyperlordotic ALIF interbody spinal fusion system.
Tesera SA is a porous titanium stand-alone anterior lumbar interbody fusion system featuring a four-screw design and a locking cover plate to prevent screw back-out. Implants are now available in 7˚, 12˚, 17˚, 22˚ and 28˚ lordotic angles with varying heights and footprints for proper intervertebral height and lordosis restoration, along with advanced instrumentation designed to reduce operative steps.
All Tesera implants utilise additive manufacturing (3D printing) and a proprietary, patent-pending design to create a roughened, highly porous surface structure that allows for bone attachment and in-growth to the implant. Renovis offers multiple 3D-printed, porous titanium implant systems for interbody spinal fusion, including anterior cervical, anterior lumbar, as well as posterior lumbar options.