— Press Release —
Redlands, CA / Austin, TX (March 30, 2016) – Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera™ SC – Porous Titanium Cervical Interbody Fusion System.
Tesera SC is a porous titanium stand-alone cervical interbody fusion system featuring 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.
All Tesera implants utilize additive manufacturing (3D printing) and a patent-pending design to create a highly porous surface structure that allows for bone ingrowth to the implant surfaces, maximizing 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 of 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.
For more information on the Tesera porous structure, visit teseratrabeculartechnology.com.
About Renovis Surgical
Renovis Surgical Technologies, Inc. was founded in 2009 with the express mission of creating the highest quality implants for orthopedics, spine and trauma and delivering those implants to the healthcare marketplace at a value. The company is based in Redlands, California, with additional operations in Austin, Texas.
For additional information on the Company, please visit renovis-surgical.com.
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