FDA Clears MedCAD’s 3D Printed Guides That Could Cut Surgery Time

April 14, 2026 by Joris Peels 3D Printing 3D Software Business Medical 3D Printing

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MedCAD has gotten FDA 510(k) clearance for the AccuStride lower leg tibia and fibula system. The patient-specific surgical planning and surgical guide tool can speed up the orthopedic surgeon’s workflows. Previously, the firm had gotten clearances for its fixation plates and guides. Now the company can offer a complete solution from CT scans to 3D printed guides for feet and ankles, as well as for the tibia and fibula.

MedCAD CEO Nancy Hairston explained,

“MedCAD’s newly announced, patient-matched surgical guides are unlike anything else available for surgeons who routinely perform complex or revision lower leg region cases. Interest from leading orthopedic specialists eager to use our solutions for multiple pathologies is very promising, and we expect these custom 3D printed devices to reduce the frequency and duration of surgeries and deliver high-quality, durable outcomes. 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 has been building a strong reputation by putting cutting-edge planning technology into surgeons’ hands so they can deliver life-changing outcomes for the people they heal. With AccuStride, we recognized that when one part of a lower leg is experiencing problems, significant issues can show up in other areas as well, and with our advanced, holistic approach, the outcomes are unmatched, and the possibilities are virtually endless.”

AccuStride. Image courtesy of MedCAD.

The company also offers vat-polymerized anatomical models, and all their parts are made in Texas, reaching US-based customers in about 5 days. The guides themselves are LPBF titanium. Additionally, the company has solutions for CMF, trauma, and cranial implants. A complete lower extremity solution will offer the same workflow to a group of hardworking people looking to save time and simplify their working lives. If they can be helped with their precision and work faster, surgeons can gain real, tangible benefits from these kinds of products.

We’ve seen Materialise really pioneer this market to great effect over the years. And the benefits can be enormous, not only in reducing errors but also, for example, in reducing surgeries by 3 hours. Depending on where you are, an Operating Room could cost $ 5,000 an hour. So, for the insurance system, hospitals, doctors, and patients, the payoff is immediate and real. The other things, fewer errors and more precision, are more difficult to measure, but just in saving time, this technology has a great ROI. More importantly, it offers a strong return on investment for all participants in the value chain.

And of course, once a hospital system settles on your solution, they may continue to use it forever. Every surgeon could just use your planning tool and get your guides for every surgery that needs them. New surgeons will be trained on your system, and from their first real procedures, will be locked into your way of doing things. This kind of business could therefore not only save everyone a lot of money but also be a very sticky business for a very long time while doing so.

What’s more, your software will be an important, repeatedly used, critical interface for surgeons. So if you had an automated segmentation tool for CT scans, you could add it to this tool and offer it for an extra fee. If you had a way to store MRI scans in the cloud and offer them to patients, you could add this to the tool as well. So it can become a focal point for the surgeon’s life, her main software tool day to day. And that is very powerful.