Medical device firm MedShape has obtained 510(k) approval from the US Food and Drug Administration for its FastForward Bone Tether Plate.
The Bone Tether Plate features firm’s latest technology platform and the 3D printing of medical grade titanium alloy (Ti-6AL-4V), which helps in fabrication of devices with complex and customizable geometries.
MedShape chief technology officer Dr Ken Gall said: "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.
"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."
In a bid to surgically correct hallux valgus deformities that preserves and protects the native bone anatomy, the plate serves as the primary component in the FastForward Bunion Correction System.
The company also received 510(k) approval for the FastForward PEEK Screw System, which is used in conjunction with the Bone Tether Plate to provide better fixation of suture tape in the first metatarsal.
MedShape will exhibit the FastForward System at the American College of Foot and Ankle Surgeons (ACFAS) Annual Scientific Conference, which will be held from 19 to 21 February in Phoenix, Arizona.
The entire FastForward Bunion Correction System is part of the firm’s foot and ankle product portfolio, which also comprises DynaNail TTC Fusion System and Eclipse Soft Tissue Anchor.