Receiving U.S. Food and Drug Administration (FDA) 510(k) clearance can take a huge amount of time, so when it’s granted to a 3D printing application, the achievement should be noted as quite significant. Regulations can exist for good reason and, in the medical and food industry, I think most people generally prefer reliability and security over sussing it out for themselves. In Atlanta, a company called MedShape, Inc., a manufacturer of orthopedic devices made with advanced material technologies, announced that the company had received FDA 510k clearance for its FastForward™ Bone Tether Plate.
The Bone Tether Plate, as well as other “devices with complex and/or customizable geometries” from MedShape, is 3D printed from medical grade titanium alloy (Ti-6AL-4V) as the primary component of what the company is calling the “FastForward Bunion Correction System”. The system, they claim, is a “new approach to surgically correct hallux valgus deformities that preserves and protects the native bone anatomy.”
Many people know what bunions are, but, personally, I wasn’t aware of how serious this condition can get. The Hallux valgus deformity (or bunion) can be a debilitating foot condition that affects 23% of people age 18-65 each year. Unaware of how serious it can get, one might not understand just how rough the treatments can be. A common treatment is surgery that involves “cutting, realigning and fusing the first metatarsal (osteotomy) or fusing the metatarsal-cuneiform joint (Lapidus).” As you can imagine, this kind of procedure involves long recovery periods and complications, including “nonunion, avascular necrosis, and limb shortening.” Yeouch.
An alternative approach that doesn’t involve cutting your toes up, is a treatment consisting of a “suture-button” implant and the placing of suture material between the first and second metatarsals. This also has complications, according to peer-reviewed studies, such as the likelihood of “second metatarsal fractures due to stress concentrations created by the suture-button implant and the requirement to drill through the second metatarsal.” Ugh, that sounds horrible.
MedShape is touting the FastForward Bone Tether Plate as a breakthrough in bunion correction. By allowing suture tape to be securely and safely wrapped around the second metatarsal, it’s possible to eliminate the need to drill through the bone. 3D printed in titanium, the Bone Tether Plate has a customizable geometry than can closely match the second metatarsal anatomy, optimizing the distribution of stresses on the bone. The device also has a looped portion that allows the suture tape to hold the plate in place, without the need to drill bone screws into toes. Yup, that sounds better.
Dr. Ken Gall, Chief Technology Officer of MedShape and professor of Materials Science and Engineering at the Georgia Institute of Technology, said of device, “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. 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.”
MedShape, Inc. is a privately held company that is hoping to “commercialize a portfolio of surgical solutions that use its patented new material technologies to address the increasing demand for improved sports medicine, joint fusion, and musculoskeletal trauma products.” If you happen to be in Phoenix, Arizona this month, you could see MedShape demonstrating its FastForward System at the American College of Foot and Ankle Surgeons (ACFAS) Annual Scientific Conference, held from February 19th-21st.
Lesson: Bunions are no joke, and neither are titanium 3D printing medical companies that are trying to eliminate drilling through your toes as part of a traditional surgical treatment.
