Medical device firm Osseus Fusion Systems has announced that its Aries family of 3D printed lumbar interbody fusion devices have received FDA 510(k) clearance. The approval marks one of the largest FDA clearances for a family of 3D printed spinal devices of that kind.
Based in Dallas, Texas, Osseus Fusion Systems is a medical device manufacturer that is focused on the development of new medical products and treatments that are minimally invasive. The company has developed a range of medical products so far including its Black Diamond Pedicle Screw System, White Pearl Anterior Cervical Plate and a few more.
Its newly approved Aries family of lumbar interbody fusion devices is, the company says, one of the most comprehensive groups of 3D printed devices in the spinal and orthopedic industries. The family, comprising of Aries-TS, Aries-TC, Aries-A, Aries-L and Aries-O offers implant solutions for lateral (LLIF), anterior (ALIF), straight and curved transforaminal (TLIF) and oblique (OLIF) procedures.
The 3D printed devices are constructed from a highly porous titanium metal which has been optimized for bone integration and fusion. The creation of the implants has been enabled largely by Osseus’ proprietary 3D printing platform, PL3XUS. Interestingly, the company says its titanium implants are some of the most porous spinal implants out there, with porosity rates of 80% or higher.
“We are thrilled to launch the Aries family of 3D printed lumbar interbodies,” said Eric Hansen, Co-Founder and CEO of Osseus. “The clinical benefits of 3D printed titanium speak for themselves and Osseus is poised to capture market share in an exponentially growing industry like never before. Osseus is unique in our ability to bring surgeon-inspired implants to market quicker than any competitor, and our focus on R&D delivers unparalleled performance and quality to our surgeons and patients.”
The 3D printed medical devices also integrate a proprietary mesh lattice which acts to reduce stiffness and to maximize bone graft packability. In other words, the mesh lattice structure is specifically designed to encourage bone cell fixation and proliferation, ultimately resulting in faster recovery times after implantation.
To meet specific patient demands, Osseus offers its Aries lumbar interbody fusion devices in a range of sizes and lordotic angles. Within the medical industry, additive manufacturing is increasingly enabling patient-specific solutions—for implants, surgical guides and more.
“As a surgeon, it’s very exciting to participate in the device development process and see your ideas brought to life so quickly,” commented Dr. Sam Joseph, Jr., who worked alongside Osseus. “Using 3D printing, we were able to go from design, to prototype, to finished product much faster than with traditional manufacturing—which means patients get access to more advanced treatments sooner, too.”
The recent FDA clearance for its medical device family marks Osseus’ fourth FDA 510(k) clearance.