On August 12, 2019, spinal implant and tool manufacturer Nexxt Spine recently announced that SLM metal 3D printed NEXXT MATRIXX independent cervical interbody fusion system has been approved by the US FDA.
This independent cervical interbody fusion system is the latest in the NEXXT MATRIXX series and is currently available for pre-order from its dealers. Like other products in the NEXXT MATRIXX series, the freestanding cervical spine system is manufactured using GE Additive's Concept Laser Mlab 3D printer (based on SLM laser metal 3D printing technology).
It is reported that this device has passed FDA 510 (k) clearance. Globally, there are many metal 3D printed orthopedic implants approved for marketing based on EBM electron beam and SLM laser metal printing, but most of China's current approvals are printed by EBM technology. Domestic metal 3D printing manufacturer Hanbang Technology and others are also using SLM laser metal printing technology to cooperate with professional medical device companies to explore orthopedic implants.
The independent cervical interbody fusion system is designed to treat patients with degenerative intervertebral disc disease. As an auxiliary method for one or two consecutive horizontal fusions, it is highly anticipated by the market. Nexxt Spine is working hard to bring this product to market.
Nexxt Spine increased its investment in additive manufacturing earlier this year, increasing the number of GE Additive Concept Laser machines to five in April, and said it would accelerate product development and achieve leapfrog development from R & D to mass production. The introduction of the freestanding cervical spine system is a good proof.
This is not the company's first FDA approval. In 2012, Nexxt Spine's new Honour cervical and lumbar fusion cages produced by Solvay's Zeniva polyetheretherketone (PEEK) were awarded FDA 510 ( k) Certification. However, the product was not produced using 3D printing.
Other FDA-certified interbody fusion cages
German medical device manufacturer Emerging Implant Technologies (EIT) has been at the forefront of advanced surgical implant technology for many years and is particularly good at 3D printing. Its FDA-approved implants have improved material properties and are tailored to the patient's anatomy, using 3D scanning and 3D printing technology. Recently, the company announced that its multi-layer 3D printed cervical fusion cage has been approved by the US Food and Drug Administration (FDA) for a variety of injuries / defects from the middle of the spine to the top.
The multi-layer cervical fusion cage is manufactured by EIT using its signature Cellular Titanium technology. Cellular titanium devices are 3D printed using selective laser melting technology. By precisely programming the movement of the laser, EIT was able to create a core that mimics bone cancellous ("sponge") and cortical (hard) structures. When implanted in the body, the bionic lattice-like structure causes tissue to grow in the center and join pieces of bone fragments together.
3D printed interbody fusion cages have been recognized by the market. In 2018, Michigan-based medical technology company Stryker (Stryker) 3D printed Tritanium (titanium alloy) TL curved lumbar vertebrae has been awarded American food And the FDA's 510 (k) license.
3D printing is helping surgeons of all disciplines to improve their surgery with more precise surgical planning and more biocompatible implants. Those who do spine surgery are no exception, and medical technology company Stryker just launched a new 3D printing solution for lumbar spine fixation.
The product that has just obtained a 510 (k) license from the US Food and Drug Administration is the titanium alloy TL posterior lumbar spine, a 3D printed interbody fusion cage for lumbar fixation. Hollow implants consist of a unique configuration of solid and porous structures, both of which are 3D printed using Stryker's proprietary additive manufacturing process, AMagine, for implant fabrication.
CFDA-certified 3D printed interbody fusion cage in China
Aikang owns CFDA-certified products for 3D printed interbody fusion cages. It is manufactured using GE Additive's Arcarm electron beam molten metal 3D printer. In its published product manual, you can clearly understand the advantages and models of this product. And how to use it.