Dallas-based MedCAD has received U.S. Food and Drug Administration 510(k) clearance for its AccuStride Foot and Ankle System, marking the company’s entry into the lower extremities area.

The patent-pending AccuStride’s design as well as the company’s proprietary software will enable foot and ankle surgeons to correct multiple related pathologies in a single procedure. MedCAD also manufactures patient-specific, custom-designed implants, including virtual planning and surgical devices.

“MedCAD’s newly announced, patient-matched solution is unlike anything else available for surgeons who routinely perform complex or revision cases in the treatment of the entire foot,” MedCAD President/CEO Nancy Hairston said. “We have experienced a surge in inquiries and interest from foot and ankle orthopedic specialists who are eager to use our “whole foot” solutions for multiple pathologies, and we expect these custom 3D printed devices to reduce the frequency and duration of surgeries, and to deliver high quality, durable outcomes.”

The AccuStride System is designed to improve proximal phalanx and metatarsal arthroplasty outcomes, and to provide custom solutions for Lapidus revisions and cavus foot corrections. Its components are constructed of UV-curable acrylate polymers or titanium alloy materials and can be delivered in as few as five days after medical imaging and surgeon design approval. The system should be used only in patients ages 12 and older.

“The goal of MedCAD’s portfolio of patient-matched product solutions is to provide surgeons with customizable options that are as anatomically unique as their patients,” Hairston stated. “MedCAD has been building a strong reputation for putting planning technology into the hands of surgeons so they can deliver life-changing outcomes for the people they heal. With AccuStride, we recognized that when one part of a foot is experiencing problems, significant issues can show up in other areas as well, and with our advanced, wholistic approach, the outcomes are unmatched, and the possibilities are virtually endless.”

MedCAD is a privately held medical technology company that designs and produces patient-matched devices. Harnessing precise imaging, surgical experience, and advanced design and manufacturing technologies, MedCAD creates personalized, patient-matched medical devices and surgical plans for cranial defects, oral surgery, CMF trauma, and reconstructive surgical procedures. The approach is totally patient-customized, with every device and every procedure planned and manufactured in-house in cooperation with a patient’s surgeon. By minimizing surgical complexity and procedure time, MedCAD technology enables superior patient outcomes throughout intervention, rehabilitation, and recovery.