All 3D Printing Articles (OrthoStreams) MEDSHAPE: 510(K) FOR BONE TETHER PLATE (Orthopedics This Week) MedShape, Inc. has announced that the company has received FDA 510(k) clearance for its FastForward Bone Tether Plate, a product featuring the company’s latest technology platform: the 3D printing of medical grade titanium alloy “that allows for the fabrication of devices with complex and/or customizable geometries.” The plate is the main component of the FastForward Bunion Correction System, “a new approach to surgically correct hallux valgus deformities that preserves and protects the native bone anatomy.” According to the February 2, 2015 news release, tethering suture material between the first and second metatarsals is one alternative bone-sparing approach to treatment. “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 FastForward 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 d...
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