MedCAD's AccuStride® Receives 510(k) Clearance for New Entry into Foot and Ankle Marketplace

DALLAS, March 26, 2025 /PRNewswire/ -- Dallas-based MedCAD has announced the 510(k) clearance of its AccuStride^® Foot and Ankle System, making these patient-specific precision devices available to surgeons. The unique design of these devices, coupled with the company's proprietary software, will enable foot and ankle surgeons to correct multiple related pathologies in a single procedure. The patent-pending AccuStride^® System marks the company's first offerings for lower extremities; MedCAD is also a leading manufacturer of patient-specific, custom-designed cranial and maxillofacial reconstruction 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," said Nancy Hairston, CEO and president of MedCAD. "We have experienced a surge in inquiries and interest from leading foot and ankle orthopedic specialists who are eager to use our 'whole foot' solutions for multiple pathologies, and we expect these custom 3-D 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 receipt of medical imaging and surgeon design approval. The system is intended for use in patients 12 years 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," said Hairston. "MedCAD has been building a strong reputation for putting cutting-edge planning technology into the hands of surgeons so that 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."

About MedCAD

MedCAD is a Dallas-based, privately held medical technology company built on an innovative approach to the design and production of patient-matched medical 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 100% 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.

SOURCE MedCAD