Dallas, Texas-based Osseus Fusion Systems has announced that the FDA cleared its family of 3D-printed lumbar interbody fusion devices, brand named Aries. The 510(k) cleared devices are made of “highly porous titanium material, which is optimized for bone fusion and biological fixation using PL3XUS, Osseus’ innovative and proprietary 3D-printing technology.”
CEO, Eric Hansen told OTW, “During the FDA approval process, Osseus demonstrated that the Aries Lumbar Interbody system passed all predicate system requirements for mechanical strength, biocompatibility, cleaning, sterilization, and a variety of other factors. We took extensive care in ensuring that our five different implants would each pass all requirements based on their surgical needs and requirements. Osseus thrives on surgeon interaction and creativity.”
“These surgeons influence and direct our engineers every step of the way and we work closely with the best facilities in the world for manufacturing, testing, and cleaning our products. Osseus prides itself on innovation and creativity, and we ensure to hire the top entrepreneurial and driven talent in the industry which helps us continuously utilize new technologies and remain ahead of the curve.”
“As a small company, Osseus is able to take advantage of the newest technology and software options in the 3D printing industry. This will continue to set us apart from larger companies who are unable to move quickly. I also believe we are leading the pack in the latest and greatest 3d printers available.”
Lead engineer Asher Breverman explained the details of the production process, “Osseus uses Selective Laser Melting printing processes to manufacture the device and employs a range of post-processing techniques to optimize the micro-surface topology.”
“Our implants employ a 700-to-800-micron pore structure in multiple axes to help facilitate bone growth onto and throughout the device. This range has been shown to be both ‘designed to facilitate’ bone cell fixation and also compatible for the packability of most biomaterials and bone grafts. As with everything, picking the right lattice and micro-surface topologies is a balance of multiple patient needs, design inputs, and functional requirements for the device.”
“Additionally, the implants range in porosity to upwards of 80%. When an implant, specifically a lumbar interbody, with that much bone graft and biomaterials, the disc space is more likely to fuse. Our multiple axes mesh helps facilitate greater graft packability by increasing the porosity by 50% compared with conventional titanium or PEEK lumbar interbodies. In fact, our implant is almost 100% more porous compared to one of its predicate devices used in the FDA submission.”
“This is a testament to the level of innovation and pushing designs to the next level that Osseus employs. We use a variety of proprietary post-processing steps, tools, and materials to treat the implant from the ‘green’ (i.e., right off the printer) to the fully-packaged final implant that is ready to be implanted inside a patient.”
“During the R&D process, we worked closely with our design team members to visualize the implants under a variety of imaging settings (X-fay, fluoroscopy, MRI, CT) to provide an unparalleled surgical experience. We are excited to work with several key surgeons to conduct clinical studies to quantify the benefits of Aries devices to a much greater extent than is capable to us as a small and scrappy medical device company.”
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