ATLANTA (February 2, 2015) – MedShape, Inc., the industry leader in orthopedic devices using advanced material technologies, announced today the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its FastForwardTM Bone Tether Plate. The Bone Tether Plate features MedShape’s latest technology platform, the 3D printing of medical grade titanium alloy (Ti-6AL-4V) that allows for the fabrication of devices with complex and/or customizable geometries. The plate serves as the primary component in the FastForwardTM Bunion Correction System, a new approach to surgically correct hallux valgus deformities that preserves and protects the native bone anatomy. MedShape will showcase the FastForwardTM System this month at the upcoming American College of Foot and Ankle Surgeons (ACFAS) Annual Scientific Conference February 19th-21st in Phoenix, Ariz.
Hallux valgus deformity (or bunion) is a prevalent and debilitating foot condition that affects 23% of people age 18-65 each year.1 Traditional surgical approaches 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.
The FastForwardTM Bone Tether Plate represents a breakthrough in bunion correction by allowing suture tape to be securely and safely wrapped around the second metatarsal 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 FastForwardTM 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 FastForwardTM 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 FastForwardTM 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.”
About MedShape, Inc.:
MedShape, Inc. is a privately held medical device company working to develop and commercialize a portfolio of surgical solutions that use patented material technologies to address the increasing demand for improved sports medicine, joint fusion, and musculoskeletal trauma products. For more information, visit www.medshape.com.
1Nix S, Smith M, Vicenzino B. Prevalence of hallux valgus in the general population: a systematic review. Journal of Foot and Ankle Research, 2010; 3(1): 21-30.
FastForwardTM is a licensed trademark of MedShape, Inc.