MedCAD Gets FDA’s 510(k) Clearance for Its AccuPlate Patient-Specific Plates
MedCAD has received the FDA’s 510(k) market clearance for its AccuPlate patient-specific plates for mandibular reconstructive surgery.
The plates are intended for use in stabilizing bone after an osteotomy or traumatic event, with or without bone grafts, according to the Dallas, Tex.-based company.
Each plate is customized based on the patient's anatomical data in consultation with MedCAD and the surgeon, and milled out of implant-grade titanium. The custom designs avoid the need for plate bending, saving time in the operating room and optimizing surgical outcomes, the company said.