MedShape, Inc., has received U.S. FDA 510(k) clearance for its FastForward™ Bone Tether Plate, the primary component in the company’s FastForward Bunion Correction System.
Traditional surgical approaches to correction of Hallux valgus deformity (or bunion) have involved cutting, realigning and fusing the first metatarsal (osteotomy) or fusing the metatarsal-cuneiform joint (Lapidus). However, these procedures are associated with long recovery periods and complications including nonunion, avascular necrosis, and limb shortening. Tethering suture material between the first and second metatarsals has been described as an alternative bone-sparing approach to reduce the deformity. However, peer-reviewed studies have reported the occurrence of second metatarsal fractures due to stress concentrations created by the suture-button implant and the requirement to drill through the second metatarsal.
Such was the challenge faced by MedShape. Its FastForward Bone Tether Plate allows suture tape to be securely and safely wrapped around the second metatarsal, thereby eliminating the need to drill through the bone. Thanks to the new 3D printing technology, the Bone Tether Plate is equipped with several unique design features, including an overall geometry that closely matches the second metatarsal anatomy so that stresses are optimally distributed on the bone and a looped portion that allows suture tape to pass and securely hold the plate in place without the need for bone screws.
In addition, MedShape received 510(k) clearance for its FastForward PEEK Screw System used in conjunction with the Bone Tether Plate to provide fast, reliable fixation of suture tape in the first metatarsal. The entire FastForward Bunion Correction System joins MedShape’s growing foot and ankle product portfolio which includes the DynaNail® TTC Fusion System and Eclipse Soft Tissue Anchor.
“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 Dr. Ken Gall, chief technology officer of MedShape and professor of Materials Science and Engineering at the Georgia Institute of Technology. “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.”
Source: MedShape, Inc.