Renovis Surgical Technologies, Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market posterior lumbar Tesera® porous titanium interbody fusion systems.
These systems feature implants for direct posterior (PLIF) or transforaminal (TLIF) approaches in both straight and curved options. Multiple heights, widths and lengths are available to better fit varying patient anatomies. All Tesera implants are produced through additive manufacturing (3D printing) and the company's proprietary Tesera Trabecular Technology®, a highly porous structure that allows for bone attachment to implant surfaces and the potential for biologic fixation deep into the pore structure for long-term stability.
This is the fifth 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 October of 2013, the Tesera acetabular system for total hip reconstruction was cleared in April of 2014, the first-generation Tesera posterior lumbar interbody family was cleared in March of 2015, and the Tesera SC system for stand-alone anterior cervical fusion was cleared in March of 2016.