OrthoGrid Systems’ PhantomMSK™ Platform Receives FDA 510(k) Clearance for Novel Distortion Adaptation Technology in Orthopedic Surgery (press release)
OrthoGrid Systems, Inc., a leading innovator in intraoperative surgical imaging, workflow efficiency and decision-making support in orthopedic surgery, today announced that the US Food & Drug Administration has granted a 510(k) clearance for the company’s novel PhantomMSK™ Orthopedic Platform. As a result of this critical milestone, OrthoGrid intends to embark on a national educational campaign about the importance of recognizing and correcting for fluoroscopic (x-ray) distortion for physicians performing orthopedic surgery.
“Fluoroscopy is utilized in most Direct Anterior Approach hip arthroplasty procedures, as it reveals real-time implant position and anatomic landmarks. But until now, there has been virtually no method to correct the highly variable distortion present in all fluoroscopic x-rays due to electromagnetic interference,” noted Charlotte-based orthopedic surgeon, John Masonis, MD. “The PhantomMSK™ System has achieved a new level of functionality with the novel distortion adaptation tool, and I am pleased to bring th...
