MedCAD Secures First of its Kind FDA 510(k) Clearance for AccuStride Fixation Plates

MedCAD has received 510(k) clearance from the U.S. Food and Drug Administration for its AccuStride™ fixation plates, completing the company’s customised foot and ankle surgical system. 

Together, the implants, guides and software are designed to allow surgeons to correct several foot and ankle conditions during a single operation.

AccuStride provides bespoke solutions for complex cases, including deformities, revision surgeries, trauma, and conditions linked to arthritis or diabetes. 

The components are made using UV-curable polymers or titanium alloy and are individually designed based on medical imaging. 

Production and delivery can be completed within five days of surgeon approval. The system is cleared for use in patients aged 12 years and above.

The technology aims to give surgeons a fully tailored approach to treating multiple pathologies across the foot. 

By matching the implant design to each patient’s anatomy, MedCAD expects the system to improve surgical fit, reduce complications and shorten recovery times.

MedCAD is already known for custom cranial and maxillofacial implants that incorporate digital planning tools. 

With this latest clearance, the company aims to expand its presence in orthopaedic care and support more efficient, durable outcomes for patients undergoing foot and ankle procedures.