MedCAD has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its AccuStride fixation plates for use in foot and ankle procedures. 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.

The latest AccuStride clearance follows an FDA authorization this past spring for its foot and ankle guides and planning system.

“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.,” MedCAD President/CEO Nancy Hairston stated. “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 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 medical imaging receipt and surgeon design approval. The system is used in patients ages 12 and older.

“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,” Hairston stated. “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 also manufactures patient-specific, custom-designed cranial and maxillofacial reconstruction implants, including virtual planning as well as surgical devices. The device is manufactured and designed to the specific individual for implantation.

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

MedCAD is a Dallas-based, privately held medical technology company built on an innovative approach to designing and producing 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 patient-customized, with every device and procedure planned and manufactured in-house in cooperation with a patient’s surgeon.