September 15, 2021 08:00 ET | Source: MedCAD MedCAD
Dallas, September 15, 2021 (Global News Agency)-After months of development and basic work, MedCAD is proud to officially announce that the FDA 510(k) mandibular reconstruction surgery patient-specific bone plate has been approved by the FDA 510(k) market.
"We are very happy to bring AccuPlate to the market. This is a feature-rich product that is perfect for our customized surgical solution portfolio," said Nancy Hairston, President and CEO of MedCAD. "Our customized products are designed to help surgeons best meet the needs of individual patients, and AccuPlate is exactly that."
AccuPlate® MedCAD® AccuPlate® patient-specific bone plates are used in mandibular reconstruction surgery, with or without bone grafts, to stabilize bones after osteotomy or traumatic events. The design of each plate is based on patient scan anatomy data negotiated with MedCAD and the surgeon, and is milled from pure implant-grade titanium. Because AccuPlate's patient-matched design does not require curved plates, it saves time in the operating room and optimizes surgical results. AccuPlate is uniquely designed to meet the needs of every patient and surgeon with a customizable mandibular plating solution.
Combining the AccuPlate® and AccuPlan® systems with MedCAD's AccuPlan system 510(k), AccuPlate benefits from the entire surgical planning experience, including guided fixation holes, osteotomies and positioning, as well as patient-specific design and comprehensive surgical planning. For example, the surgeon can specify features such as the location of the fixation hole and the thickness of the plate to achieve planned patient results related to graft placement in the reconstruction of the mandible with the free fibular flap. Then optimize the AccuPlate design specifications for use with guides and splints to provide customized surgical solutions.
The market clearance of AccuPlate brings customers a new fixed electroplating product line for patients. As an innovator of patient-matched medical equipment, MedCAD continues to build on the power and flexibility of the AccuPlan system.
"With the approval of AccuPlate 510(k), years of intense product development work has clearly paid off. Our involvement in titanium milling is an exciting new adventure. Our only goal is to adopt new materials, new processes and New products and services to meet customer needs," said Brian Buss, Executive Vice President of MedCAD. "AccuPlate is a compelling new product that has secured important distribution partnership opportunities and promoted our vision of'recovering humans one patient at a time'."
About MedCAD MedCAD is a private company based in Dallas, Texas. Founded in 2007, MedCAD is a flexible innovator in the patient-matched medical device industry, providing skull implants, patient-matching electroplating, surgical planning, and 3D modeling products and services. MedCAD is known for its high-quality products, excellent customer service and concierge style case management.