Additive Manufacturing (Three-dimensional printing 3DP), is a very rapidly growing industry trend in the area of spinal surgery. The introduction of additive manufacturing into the spinal industry started a revolution enabling increased complexity of implant design and patient-specific solutions.
Why Additive Manufacturing is the TREND and the Leading Companies are launching 3D Cages?
- Porous titanium scaffold optimizes bone ingrowth: The most well-known example of porous metal implants are spinal interbodies for interbody fusion. In this technique, the entire intervertebral disc between vertebrae is removed and a titanium device is placed between the vertebra, with or without a bone graft, to maintain spine alignment and disc height. Porous titanium implants are of interest since they exhibit improved strength and lower stiffness compared to the solid metals, and are more aligned with human bone properties. Traditionally, polyetheretherketone (PEEK) interbodies were used for interbody fusion; however, their lack of porous structure presents a disadvantage. By using porous titanium implants, initial fixation of the implant is improved. Additionally, long term stability is ensured due to the ability for bone to grow into the open, interconnected porosities.Additive manufacturing allows to produce porous titanium cages, that combine the biocompatibility of titanium material with improved biomechanical and bone incorporative qualities. The porous titanium scaffold influence the bony fusion process by combining specific macro structural, micro structural and nano structural characteristics.
- Reduce Costs: While durability of the device and improved patient outcomes are most important, cost of production is always an underlying consideration. Significant productivity improvements have been implemented to lower the production costs of porous implants manufactured via DMP. The best example is the cost competitiveness of spinal porous cages produced with selective laser melting, when compared to PEEK volume production of spinal cages and traditional manufactured titanium cages.
- Patient-Specific Solutions: Although this accounts for a small percentage of total medical production, this provides solution to very specific and complex cases.
Why 3D printing titanium parts is better than producing them using other manufacturing methods?
1 Greater Complexity and Resolution in Design: DMLS with titanium powder allows greater liberties with the CAD design. This includes deep groves, cooling channels in injection mold, cavities, undercuts and free form surfaces. The minimum wall thickness in DMLS using titanium is 0.3-0.4 mm, allowing incredibly detailed designs to be implemented. The produced parts can also be surface finished in a variety of ways.
2. Excellent Mechanical Properties: Titanium is a strong metal to start with. DMLS does an excellent job of preserving this strength during the manufacturing process. Instead of manufacturing multiple smaller parts before and joining them later, DMLS fuses every parts with the whole structure just as the laser creates it.
3. Accuracy in Production: Each part produced confirms to its sanctioned prototype. Typical achievable part accuracy is around +/- 50 microns.
4. Quick Turnaround Time: Depending on the size, parts can be produced in anywhere between a few hours to a few days. This ensures smooth production of the final product with any bottlenecks where final production is halted by availability of parts.
5. Re-design is Easier: If a part is re-designed, creating the newly tooled part is easy because only the CAD machine drawing of the part needs to be replaced. As such re-designing an existing part doesn’t bear a significant impact on the lead time.
Which are the 3D Cages that will compete in 2019?
Now, most of the leading companies have launched 3D printed Cages platforms. Smaller companies have followed this trend and are developping Titanium 3D implants. Last year we published and article about Additive Manufacturing in Spine and we found seventeen 3D cages in the market. Today it has almost doubled and we have listed 27 implants that will compete in 2019 and that you can visit in:http://www.thespinemarketgroup.com/category/3d-ifc/
Medtronic launched the titanium 3D printed platform – TiONIC(TM) Technology .The implant are made of titanium and the 3D printed honeycomb design acts as an osteoconductive scaffold for bony growth into the implant and provides improved mechanical load distribution across the implant.“
At Nass 2017, Nuvasive launched Modulus® XLIF® titanium implants.The new Modulus titanium implants are developed using additive manufacturing technology, or 3D printing, to create an organic, porous architecture that mimics the porosity and stiffness of bone for reduced stress shielding.
Stryker’s Spine division also introduced its Tritanium® first product 3D-printed interbody fusion cage intended for use in the cervical spine, at the North American Spine Society (NASS) Annual Meeting, Oct. 25-28, 2017.Tritanium Cages are built using Stryker’s proprietary Tritanium In-Growth Technology, a novel, highly porous titanium material designed for bone in-growth and biological fixation.structures.
K2M’s Lamellar 3D Titanium Technology™ uses an advanced 3D printing method to create structures that were once considered impractical with traditional manufacturing techniques. Starting with a titanium powder, the implants are grown through the selective application of a high-energy laser beam, allowing for the incorporation of both a porosity and surface roughness that pre-clinical data have associated with bone growth activity.
In 2014, a German medical device company EIT (Emerging Implant Technologies) was the first manufacturer to exclusively focus on spinal implants, designed and produced with additive manufacturing methods. Since then, EIT has sold over 15.000 cases performed in over 15 markets globally and recently has been acquired by Depuy.
- Tsunami Medical
- Centinel Spine
- HD Lifesciences
- HT Medical
- Nexxt Spine
- 4WEB Medical
- Camber Spine
- Silony Medical
- Captiva Spine
- Choice Spine
- Signus Medizintechnik
Which suppliers are leading Additive Manufacturing?
“Marox Corporation, headquartered in Holyoke, Massachusetts, has established a reputation as a reliable source for high quality, precision-machined components and assemblies for some of the world’s largest and most successful OEMs. In addition to a full array of the most advanced CNC machining services, Marox’s additive manufacturing capabilities enables them to provide their customers with the latest technologically inspired products available in the medical and aerospace industries. http://www.marox.com “
FMI Instrumed, Schiedam, the Netherlands, has an important focus on Additive Manufacturing in the medical device industry. Currently, the company uses metal AM to produce devices such as spinal implants, titanium hip cups and knee implants.The company reports that, in addition toAM machines installed at its facility, it also has the equipment – such as CNC machinery – and skills for the complete metal AM process to be conducted in-house.FMI Instrumed is a subsidiary of mechanical systems, modules and components supplier FMI. www.fmi-international.com