Foot and ankle specialist MedShape announced FDA 510(k) clearance of its 3-D printed FastForward Bone Tether Plate, a surgical bolt that enables less-invasive foot surgery, which does not require drilling through bone.
The titanium device is a component of the FastForward Bunion Correction System to correct bunions, which results in a foot deformity at the base of the big toe as a result of it pushing against the neighboring toe, explains the Mayo Clinic. Bunions, or hallux valgus deformities, affect nearly a quarter of people between the ages of 18 and 65, according to the release.
Traditionally, the deformity is corrected using surgery involving cutting and fusing, but MedShape says the bone tether plate allows suturing tape to be wrapped around the neighboring toe, or second metatarsal, without drilling. The company says it uses 3-D printing so that the plate matches the second metatarsal anatomy.
The FDA's 510(k) database shows that the clearance occurred in December 2014. The FDA classifies the device as a washer, nut or bolt, and says the device received strength testing using a variety of suture sizes and materials.
The FDA deemed the bone tether plate substantially equivalent to the Arthrex Mini TightRope, which also enables a suture and bolt approach to hand surgeries for conditions such as thumb instability.
"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," said MedShape Chief Technology Officer Dr. Ken Gall, an engineering professor at the Georgia Institute of Technology.
Besides the Bunion Correction System, MedShape's website says that it offers four other orthopedic devices for foot and ankle surgery.
- read the release
- here's the FDA's approval letter