Stryker and Omegasonics Receive Important Industry Certifications for 3D Printed Spinal Implant and Ultrasonic Cleaning Unit
In the winter of 2016, medical device manufacturing company Stryker decided to commit to 3D printing and announced the launch of a 3D printed spinal implant, as well as a planned 3D printing manufacturing facility. Soon after, the company’s Spine division debuted its 3D printed Tritanium posterior lumbar (PL) cage spinal implant, and completed a successful clinical trial on the implant last fall. Now, Stryker’s Spine division has a new announcement regarding its 3D printed offerings – its Tritanium C Anterior Cervical Cage has just received the all-important 510(k) clearance from the US Food and Drug Administration (FDA).
The interbody fusion cage, which is meant to be used in the cervical spine, is just the latest in a long line of 3D printed spinal implants and devices to receive FDA clearance: in 2017 alone, Medicrea filed for clearance of its 3D printed titanium spinal interbody devices, and several other companies, such as SI-BONE, EIT, and Camber Spine Technologies, received their FDA clearance this summer. As 3D printers and medical regulations continue to be looked at very closely and the FDA releases more guidance on 3D printing, these types of clearances and approvals are increasingly important to lock in.
Stryker’s proprietary Tritanium In-Growth Technology, a highly porous titanium material designed for biological fixation and bone in-growth, was used to manufacture the company’s C Anterior Cervical Cage. The material, constructed using the company’s proprietary AMagine approach to 3D printed implant creation, was inspired by cancellous bone microstructure and uniquely designed to make a “favorable environment for cell attachment and proliferation.”
“We are excited to introduce the Tritanium C Anterior Cervical Cage following the successful launch last year of our Tritanium Posterior Lumbar Cage. The benefits of additive manufacturing to create highly porous spinal implants that are ‘engineered for bone’ are becoming increasingly clear. Additive manufacturing allows us to push beyond conventional manufacturing techniques to address design complexity and achieve previously unmanufacturable geometries, while delivering the performance, reproducibility, and quality our customers have come to expect,” said Bradley Paddock, the President of Stryker’s Spine division.
The cervical cage has smooth, posterior edges that can help with insertion, and protect the surrounding soft tissue. It has lateral windows that help lower its stiffness and subsidence (motion of a surface as it shifts downward), and an open central graft window, which helps with bone graft containment; additionally, it has serrations on both the superior and inferior surfaces that were designed for bidirectional fixation, as well as to increase the possible surface area for the endplate to touch the cage. Intended use is in cervical interboduy fusion procedures for patients who are skeletally mature and have degenerative disc disease, used with an autogenous and/or allogenic bone graft. The Tritanium C Anterior Cervical Cage will be available for surgeons to use in Q4 2017.
For manufacturers around the world, it’s also extremely important to receive the proper standards and certifications. Back in July, ultrasonic cleaning systems manufacturer Omegasonics, which uses its ultrasonic technology to make 3D print post-processing quick and simple, secured Canadian Standards Association (CSA) certification, CE Marking certification, and Underwriters Laboratory (UL) certification for its 20-gallon 1900BT cleaning unit, the precursor to its 1900BTX unit that’s used for cleaning 3D prototype parts. Now, the company announced that it’s obtained the same important agency ratings for its 187 gallon capacity SST4030 ultrasonic parts cleaner, which was created specifically to be used with the Stratasys Fortus 900mc 3D printer.
Frank Pedeflous, the President of Omegasonics, said, “Having secured these certifications for the SST4030, the industries that have embraced 3D printing technology can be confident that this ultrasonic cleaning unit will consistently perform within the safety parameters required by the CE, CSA and UL.”
The SST4030 ultrasonic parts cleaner allows for the removal of soluble support structures from 3D printed parts that are as large as 3 x 2.5 x 3 feet. Use of this technology is intended to cut down on costs, labor, and time spent in cleaning 3D printed parts.
“It used to take a full day to manually remove support material from some 3D parts,” said Armen Boyajyan, Product Finishing Manager of Stratasys Direct Manufacturing. “Now we just put the parts into the ultrasonic cleaner and do something else while they’re being cleaned. After three hours, we have nice, clean parts.”
According to Omegasonics, its cleaners work by creating high-frequency sound waves in water with electric generators – as the waves travel, tiny vacuum bubbles form and implode on any surface they come across, like 3D printed parts. The effect, called cavitation, releases huge amounts of energy at microscopic levels, and these energy bubbles can get into the tiniest cracks, crevices, and grooves to remove even the smallest of dirt particles.
CSA standards are considered to be equivalent to what’s required in terms of safety by the global safety science organization UL in America. The CSA certification means that the SST4030 meets applicable safety standards that are required by North American law, and that it has been certified by an accredited third-party laboratory. Gaining the approval of the CE means that the cleaning unit “complies with the mandatory requirements of relevant European health, safety and environmental protection legislation.”
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