FDA clears Renovis Surgical 3D-printed titanium standalone cervical cage


Renovis Surgical technologies has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Tesera SC, a porous titanium cervical interbody fusion system.

Tesera SC features a three-screw design and a locking cover plate to prevent screw backout. Implants are available in two lordotic angles with varying heights and footprints for proper intervertebral height restoration, along with advanced instrumentation designed to reduce operative steps.

Tesera implants are created by additive manufacturing (3D printing). They are designed to create a highly porous surface structure to allow for bone ingrowth to the implant surfaces. According to a company release, this can maximise strength, stability and biologic fixation.

This is the fourth product group featuring the Tesera porous titanium structure for which Renovis Surgical has received FDA clearance; the Tesera SA system for stand-alone anterior spinal fusion was cleared by the FDA in September 2013, the Tesera Acetabular system for adult reconstruction was cleared in April of 2014, and the Tesera posterior lumbar interbody family was cleared in February of 2015.