Feb.2, 2015 | By Simon
Along with the aerospace industry, the medical industry has been seeing some remarkable developments towards the future of 3D printed metals that are safe to use within the human body. While companies such as Bell Helicopters are incorporating 3D printed metals into their final manufacturing strategy for aircraft, the proof that it can be done with helicopters is reason enough to believe that the same properties could hold true for bone plates within humans.
MedShape, a privately held medical device company that develops surgical solutions and technologies for improved sports medicine, joint fusion, and musculoskeletal trauma products has announced today that they have received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for their FastForward Bone Tether Plate. The plate, which serves as one of the primary components of the company’s FastForward Bunion Correction System, features MedShape’s latest 3D printed medical grade titanium alloy (Ti-6AL-4V). The use of 3D printing as a way of fabricating the plates allow for MedShape to design their final products around the constraints of complex structures...such as those seen in existing human bone assemblies.
"The FastForward system aligns with MedShape's continued mission to develop and commercialize innovative medical devices from cutting edge materials and manufacturing technologies to address significant clinical needs," said MedShape’s Chief Technology Officer Dr. Ken Gall. "We are in the early stages of tracking clinical outcomes with this new surgical approach and are excited to extend the 3D printing material platform towards the development of other implants."
For doctors like Gall, who is also a professor of Materials Science and Engineering at the Georgia Institute of Technology, the announcement of the clearance translates to more customizable and permanent solutions for patients needing the technology.
In regards to MedShape’s FastForward Bunion Correction System, this technology means that those with hallux valgus deformities will be able to better preserve and protect their existing bone anatomy with the 3D printed titanium plate implant surgical procedure. Considering that the condition affects 23% of people aged 18-65 every year, this means that a large part of the population could soon be walking around with 3D printed titanium attached to their bones.
Previously, the traditional surgical approaches have revolved around cutting, drilling, realigning and fusing the first metatarsal or metatarsal-cuneiform joint to the second metatarsal joing. While the surgery provided some relief, it was also associated with long recovery periods and complications including nonunion, avascular necrosis, and limb shortening.
Alternatively, the FastForward Bone Tether Plate allows suture tape to be securely and safely wrapped around the second metatarsal which eliminates the need to drill through bone. Combined with the unique customization for a specific patient, the plate can be anatomically-defined to match the existing bone structure without the need for excessive and destructive drilling.
In addition to receiving clearance for the 3D printed titanium plate, MedShape also received 510(k) clearance for their FastForward PEEK Screw System - which is used in conjunction with the Bone Tether Plate. The PEEK Screw System provides a fast and reliable fixation of suture tape in the first metatarsal.
The company will be demonstrating the FastForward System this month at the upcoming American College of Foot and Ankle Surgeons (ACFAS) Annual Scientific Conference February 19th-21st in Phoenix, Ariz.
Posted in 3D Printing Applications
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It looks like an interesting product, but if the video is correct there is still selling through bone (twice). It doesn't detract from the product necessarily, but the article is unfortunately misleading.
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