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Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology™ Acetabular Devices
— Press Release —
Redlands, CA / Austin, TX (April 15, 2014) – 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 Trabecular Technology™ Acetabular System. This novel hip implant is manufactured utilizing additive manufacturing and a patent-pending design to create a highly porous structure that maximizes strength, stability and biologic fixation. This is the second product featuring the Tesera porous structure for which Renovis Surgical has received FDA clearance; the Renovis Tesera Stand-Alone ALIF Cage for spinal fusion was cleared by the FDA in October 2013.
The new acetabular system will feature both Renovis E-MAX™ and Renovis MAX™ Highly Crosslinked Polyethylene liners. These liners were designed for maximum strength and ultra-low wear; Renovis E-MAX™ contains vitamin E for additional antioxidant protection. This material was developed by polymer scientists at Massachusetts General Hospital (MGH) and Cambridge Polymer Group (CPG), both of Boston, Massachusetts.
Renovis Surgical will introduce the Tesera Trabecular Technology™ Acetabular System at this year’s Harvard Medical School Annual Advances in Arthroplasty Course, October 7-10, 2014, in Boston, Massachusetts.
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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