MedShape Gets FDA Nod for 3D-Printed Bunion Correction System

Orthopedic devicemaker MedShape said Monday that the FDA has cleared its 3D-printed FastForward Bone Tether Plate, the primary component in the company’s FastForward Bunion Correction System.

The company also received 510(k) clearance for the FastForward PEEK Screw System used with the tether plate. Together, they enable fast, consistent reliable fixation of suture tape in the first metatarsal, offering a new approach to the treatment of bunions, MedShape said.

Bunion is a debilitating foot condition that affects 23 percent of people age between the ages of 18 and 65, according to the Atlanta, Ga., devicemaker. Conventional surgical approaches involve cutting, realigning and fusing the big toe or fusing the metatarsal-cuneiform joint — procedures that require long recovery periods and can lead to serious complications.

The FastForward Bone Tether Plate — made of medical-grade titanium alloy — improves bunion correction by allowing suture tape to be securely and safely wrapped around the second metatarsal, eliminating the need to drill through the bone, MedShape said.  The 3D printing technology creates an overall geometry that matches that of the second metatarsal, distributing bone stress and allowing suture tape to secure the plate in place without the need for bone screws. — Kellen Owings