Renovis Surgical receives 510(k) clearance for 3-D printed porous titanium cervical fusion system
Renovis Surgical Technologies Inc. announced it has received FDA 510(k) clearance for the Tesera SC-Porous Titanium Cervical Interbody Fusion System.
According to a company release, the Tesera has a three-screw design and locking cover plate which prevents screw backout. Renovis developed implants in two lordotic angles with different heights and footprints for intervertebral height restoration. The system also includes advanced instrumentation which reportedly reduces steps during surgery.
The Tesera is a stand-alone device, and all Tesera implants use 3-D printing and a patent-pending design that reportedly creates a highly porous surface for bone ingrowth.