MedCAD’s AccuStride™ Fixation Plates Receive 510(k) FDA Clearance to Complete Foot and Ankle System Offering

DALLAS, Nov. 6, 2025 /PRNewswire/ -- Dallas-based MedCAD has been awarded 510(k) FDA clearance for its AccuStride fixation plates, part of a patient-specific solution available to surgeons as a complete foot and ankle (F&A) system. The company received 510(k) FDA clearance for its foot and ankle guides and planning system in March 2025. The AccuStride implant and surgical guide system coupled with the company's proprietary planning software will enable foot and ankle surgeons to correct multiple related pathologies in a single procedure.

“This is the first and the only FDA-cleared, truly patient-specific 3D-printed titanium implant and cutting guide system solution in the U.S.,” said Nancy Hairston, CEO and president of MedCAD. “There are no other truly custom foot plates on the market, and no other truly custom comprehensive system like ours.” 

The AccuStride system is designed to provide truly patient-specific custom solutions for revision procedures, deformities, arthritic or diabetic conditions, and trauma-related foot and ankle injuries. 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.

Sign up for Blog Updates