Jun 1, 2016 | By Benedict
K2M, a global medical device company, today received 510(k) clearances from the FDA for two of its 3D printed spinal solutions: CASCADIA Cervical and CASCADIA AN Lordotic Oblique. Both make use of K2M’s Lamellar 3D Titanium Technology, which allows for “bony integration” throughout the implant.
Implants are important medical devices which save and improve human lives on a daily basis. They can be made from a variety of materials, including titanium and silicone, and are used for various medical and cosmetic purposes. Of course, medical innovations come thick and fast these days, but the latest examples of 3D printed spinal implants are providing doctors and patients with particularly exciting new possibilities. For example, where once a patient might have required a piece of solid metal in their body, they can now opt for a precisely arranged porous structure which actually encourages bone growth throughout the implant. K2M’s 3D Printed Lamellar Titanium Technology, which has just received FDM clearance for two new product groups, works in exactly this way, providing a rough and porous implant that allows bone to grow right through it.
The secret to the implant’s ingenious porous structure is, of course, 3D printing. The gill-like arrangement of the K2M implants, which mimics the lamellar structure of real human bones, would have been impossible to create using any casting technique. After careful CAD design, however, the titanium structures can be brought to life with ease using a metal 3D printer. Each CASCADIA implant is created from a titanium powder which is subjected to a high-energy laser beam, resulting in a precise lamellar pattern with a 3–5 μm surface roughness. And now, thanks to FDA approval, more patients can start to feel the benefits of this unique, additively manufactured technology.
Both newly approved CASCADIA products use K2M’s 3D printed technology, but the two systems work in different ways. Designed for patients suffering from degenerative spinal disorders, the Cervical Interbody System functions as an intervertebral body fusion device, providing stabilization and support of the cervical segment of the spine. The Lordotic Oblique Interbody System, on the other hand, gives surgeons a range of anatomically designed interbodies for oblique placement through a transforaminal-lumbar approach. Both systems are cleared for use with autologous and allogenic bone graft tissue, which can be used to treat degenerative disc disease (DDD) and degenerative scoliosis.
“K2M was the first leading spine company to introduce a 3D printed titanium interbody device and is now the only company to offer a complementary allograft solution in the United States,” said K2M President and CEO Eric Major. “Through continued development efforts and subsequent product launches, K2M offers the most comprehensive portfolio of FDA-cleared 3D printed spinal devices on the market, cementing K2M as the leader in the 3D printing of spinal devices.”
After receiving FDA approval for the two 3D printed spinal implant products, K2M was able to witness the technology in action as Tom Morrison, a neurosurgeon at Polaris Spine & Neurosurgery Center in Atlanta, Georgia, carried out the first surgical case using the CASCADIA Cervical Interbody System. “I'm excited to have the Lamellar 3D Titanium Technology available for the cervical spine as it presents a balance of roughness and porosity that allows the potential for bone to grow into the implant,” Morrison said. “Additionally, the biomechanical stiffness of the CASCADIA implants are similar to PEEK and less than a more-traditional solid titanium design.”
While other K2M systems, including the CASCADIA Lateral and AN implants, received FDA clearance within the last year, the two latest additions serve to widen the portfolio of 3D printed implants still further. With medical device companies forming the backbone of the medical 3D printing world, real human backbones can now reap the rewards of groundbreaking additive manufacturing techniques. Long may it continue.
Lamellar 3D Titanium Technology features:
- Surface roughness of 3–5 μm, optimized to allow bony ongrowth
- 500 μm longitudinal channels, designed to allow for bony integration
- 70% overall porosity, resulting in a decreased radiographic signature
Posted in 3D Printing Application
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Is surgery available with the new product and where could I find more information on it?
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