FDA Approves Titanium Bone Tether Plate From MedShape

MedShape Inc. has received U.S. Food and Drug Administration (FDA) 510k clearance for its FastForward Bone Tether Plate.

The plate, 3-D-printed from medical grade titanium alloy (Ti-6AL-4V), is the primary component of the company’s FastForward Bunion Correction System, a product the company claims is a “new approach to surgically correct Hallux valgus deformities that preserves and protects the native bone anatomy.”

The Hallux valgus deformity (or bunion) can be a debilitating foot condition that affects 23 percent of people aged 18-65 each year. A common treatment for bunions is surgery that involves cutting, realigning and fusing the first metatarsal (osteotomy) or fusing the metatarsal-cuneiform joint (Lapidus). This procedure involves long recovery periods and potential complications, including nonunion, avascular necrosis, and limb shortening.

An alternative approach that doesn’t involve cutting up the toes 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.”

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 is possible to eliminate the need to drill through the bone. The Bone Tether Plate has a customizable geometry that 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.

“The FastForward system aligns with MedShape’s mission to develop and commercialize 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 3-D printing material platform towards the development of other implants,”
said Dr. Ken Gall, chief technology officer of MedShape and professor of Materials Science and Engineering at the Georgia Institute of Technology.

MedShape is a privately held company based in Atlanta, Ga., that makes surgical products for sports medicine, joint fusion, and musculoskeletal trauma.