MedCAD receives FDA clearance for patient-specific AccuStride implants in the foot/ankle joint

Dallas-based MedCAD has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AccuStride fixation plates. Back in March 2025, the company reported 510(k) clearance for its planning and guidance system in the foot & ankle (F&A) segment. With the current decision, the patient-specific system comprising implant, cutting guides, and software is complete. Target indications include deformities, revisions, arthritic or diabetic changes, and trauma-related lesions, intended for patients aged 12 and older.

AccuStride combines preoperative, data-driven planning with custom-fabricated components. The implants are made from 3D-printed titanium, while the surgical guides use UV-cured acrylate polymers. According to MedCAD, patient-specific sets can be manufactured and delivered within a few days after imaging is received and approved by the surgeon.

“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.”

Technically, the workflow relies on segmentation of the individual anatomy, virtual correction planning, and derivation of precisely fitting plate geometries along with drill and saw guides. The 510(k) clearance demonstrates substantial equivalence to previously cleared predicate devices and permits marketing in the United States.

“We have great interest from leading foot and ankle orthopedic specialists who are eager to use our ‘whole foot’ solutions for multiple pathologies – including revisions,” said Hairston. “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.”

“MedCAD is becoming known for putting cutting-edge planning technology into the hands of surgeons so that they can deliver life-changing outcomes for the people they heal,” said Hairston. “We expect these custom 3D printed devices to reduce the frequency and duration of surgeries, and to deliver high quality, durable outcomes.”

With AccuStride, MedCAD positions itself—alongside its existing portfolio of cranio- and maxillofacial patient-specific implants—for everyday orthopedic use. For hospitals looking to address varying pathologies in a single procedure, the approach offers an integrated, data-driven process from planning through sterile delivery in the OR.