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MedCAD's AccuStride® System: A Leap Forward in Orthopedic Surgery

In an era where precision and personalization are paramount in medical technology, MedCAD, a Dallas-based company, has officially received FDA 510(k) clearance for its innovative AccuStride® system. This new lower leg solution, specifically targeting the tibia and fibula regions, is designed to provide orthopedic surgeons with patient-specific tools that facilitate complex surgical procedures.

The AccuStride® system is part of a broader shift within the medical field towards customized solutions that account for individual anatomical differences. The unique feature of this system lies in its integration of custom-made surgical guides, which enhance the accuracy of surgical interventions. These guides are engineered to assist surgeons in addressing multiple related pathologies and performing osteotomies in a single operation, thereby streamlining the surgical process and potentially speeding up recovery times for patients.

This recent FDA clearance isn’t the first for MedCAD in the realm of lower extremities. Just a year prior, the company secured 510(k) clearance for its comprehensive foot and ankle guide and planning system. The momentum built throughout 2025 culminated in the licensing of its fixation plates, completing a robust suite of patient-specific solutions for foot and ankle surgeries. The culmination of these innovations within the AccuStride® system showcases MedCAD's commitment to revolutionizing orthopedic surgery with cutting-edge technology designed to meet the specific needs of each patient.

Nancy Hairston, the CEO and president of MedCAD, expressed the company's vision: "Our newly launched patient-matched surgical guides are groundbreaking for surgeons, especially for those who frequently handle complex or revision cases in the lower leg. The interest we've seen from leading orthopedic specialists has been overwhelmingly positive. We anticipate that these tailor-made 3D printed devices will markedly diminish the frequency and duration of surgical procedures, while also ensuring robust and high-quality patient outcomes."

The AccuStride® system encompasses a range of components including surgical guides, plates, and anatomical models, all designed using state-of-the-art materials such as UV-curable acrylate polymers and titanium alloys. After the surgeon approves the design, MedCAD can deliver these custom-tailored solutions in as little as five days. The system is suitable for patients aged 12 years and older, catering to a wide demographic of individuals seeking corrective orthopedic surgery.

Moreover, the system’s design allows for tactile placement of each surgical procedural step, derived seamlessly from patient imagery data coupled with the approved surgical plan. Compatibility with FDA-cleared surgical cutting and drilling instruments ensures that surgeons can easily interface these products with existing surgical tools.

The anatomical models provided by the AccuStride® system play a crucial role in helping surgeons visualize a patient’s unique anatomy, further enhancing preoperative planning and execution. Hairston noted, "Our goal is to offer surgeons customizable options that mirror the anatomical uniqueness of their patients. MedCAD has built a strong reputation on providing advanced planning technology that enables surgeons to realize life-changing outcomes for their patients. With AccuStride, we acknowledge that issues in one part of the lower leg can lead to complications in other areas, thus our holistic approach ensures unmatched outcomes with nearly limitless potential."

Beyond the AccuStride® system, MedCAD has established itself as a proficient manufacturer of bespoke cranial and maxillofacial reconstruction implants, advocating for a more personalized approach to surgical interventions that includes virtual planning and surgical devices.

About MedCAD:
Founded in Dallas, MedCAD is a privately held medical technology company noted for its innovative approach in crafting patient-matched medical devices. By leveraging precise imaging technology, surgical expertise, and advanced design methodologies, MedCAD creates personalized surgical plans tailored to cranial defects, oral surgeries, and reconstructive interventions. Their commitment to in-house manufacturing and customization enables improved patient outcomes by minimizing surgical complexities, ultimately enhancing the rehabilitation and recovery phases for patients.

As the field of orthopedic surgery continues to evolve, the introduction and implementation of solutions like MedCAD's AccuStride® system mark significant progress towards personalized healthcare, where surgical approaches honor the individual needs and anatomical subtleties of every patient.