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Mar 31, 2016 | By Tess

We often write inspiring stories about how 3D printed titanium implants have helped to save or better the lives of patients from around the world. As additive manufacturing allows for implants to be made quickly, and are customizable to fit the patient in question, there is no denying that the technology has a lot to offer the medical world. Now, with recent approvals by the U.S. Food and Drug Administration (FDA) for a number of titanium 3D printed implants, such as BioArchitects 3D printed titanium cranial plate implants, and Stryker’s 3D printed titanium PL posterior lumbar cage, there is little question that the technology is on the rise and will become increasingly present in medical institutions.

Just yesterday, American implant manufacturer Renovis Surgical Technologies, Inc. announced that one of its own designs, for a 3D printed titanium stand-alone cervical cage, had also been approved by the FDA, receiving 510(k) clearance from them. The implant, called Tesera SC, is a Porous Titanium Cervical Interbody Fusion System made using additive manufacturing technologies.

The 3D printed titanium implant features a unique design with three screws and a locking cover plate to prevent screw backout. The 3D printed stand-alone cervical cage has also been designed and made using Renovis’ Tesera Trabecular Technology, a patent-pending porous surface design structure, which allows for efficient and stable organic bone ingrowth to the implant itself. The company has also created other implants using their Tesera porous structure, each of which are 3D printed using Electron Beam Manufacturing technologies (EBM) and are made from a biocompatible titanium alloy.

The 3D printed titanium stand-alone cervical cage, which features the Tesera porous structure, is available in two lordotic angles (lordosis refers to the inward curvature of the lumbar and cervical parts of the spine) with “varying heights and footprints for proper intervertebral height restoration”. The additively manufactured titanium implant was also designed with advanced instrumentation, to effectively reduce the number of operative steps during implantation.

As mentioned, Renovis Surgical has developed other implants and products using their Tesera titanium porous structure, including the Tesera SA system for stand-alone anterior spinal fusion, which was FDA approved in 2013, the Tesera Acetabular system for Adult Reconstruction, approved in 2014, and the Tesera posterior lumbar interbody family of products, which was cleared just last year. The Tesera SC Porous Titanium Cervical Interbody Fusion System marks their fourth product group approved by the FDA.

 

 

Posted in 3D Printing Application

 

 

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