Wednesday, September 15, 2021
After months of developmental groundwork, MedCAD is proud to officially announce FDA 510(k) market clearance for AccuPlate® Patient-Specific Plates for mandibular reconstructive surgery.
“We’re thrilled to bring AccuPlate to market. It’s a feature-dense product that fits perfectly in our portfolio of Custom Surgical Solutions,” says Nancy Hairston, President & CEO of MedCAD. “Our customized products are designed to help surgeons best meet the needs of individual patients, and AccuPlate does exactly that.”
MedCAD® AccuPlate® Patient-Specific Plates are used in mandibular reconstruction surgeries to stabilize bone after an osteotomy or traumatic event with or without bone grafts. The design of each plate is based on the patient's scanned anatomical data in consultation with MedCAD and the surgeon, and milled out of pure, implant-grade titanium. Due to the patient-matched design of AccuPlate, plate bending is not needed, therefore saving time in the operating room and optimizing surgical outcomes. AccuPlate is uniquely designed to meet the needs of each patient and surgeon through a customizable mandible plating solution.
AccuPlate® and AccuPlan® System
In tandem with MedCAD’s AccuPlan System 510(k), AccuPlate benefits from the entire surgical planning experience with guided fixation holes, osteotomies and positioning, as well as patient-specific design and comprehensive surgical planning. For example, surgeons are able to prescribe features like fixation hole placement and plate thickness to achieve their planned patient outcomes relative to graft placement in fibula free flap mandibular reconstruction. AccuPlate design specifications are then optimized to work with guides and splints to deliver a Custom Surgical Solution.
AccuPlate market clearance brings customers an entirely new product line for patient-specific fixation plating. As an innovator of patient-matched medical devices, MedCAD continues to build on the power and flexibility of the AccuPlan System.
“Years of intense product development work are clearly paying off with the 510(k) approval of AccuPlate, and our foray into titanium milling is an exciting new venture. Our singular goal is to meet our customers’ needs through new materials, new processes and new products and services,” says Brian Buss, Executive Vice President of MedCAD. “AccuPlate is a compelling new product garnering significant distribution partnership opportunities and driving forward our vision of ‘Restoring Humanity One Patient at a Time.’”
MedCAD is a privately held company in Dallas, TX. Founded in 2007, MedCAD is a nimble innovator in the patient-matched medical device industry offering cranial implants, patient-matched plating, surgical planning, and 3D modeling products and services. MedCAD is known for its high-quality products, spectacular customer service and concierge-style case management.