OrthoGrid Systems’ PhantomMSK™ Platform Receives FDA 510(k) Clearance for Novel Distortion Adaptation Technology in Orthopedic Surgery
February 26, 2019
New regulatory clearance in USA further expands the clinical utility of OrthoGrid’s disruptive surgical platform engineered for universally performed orthopedic procedures.
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 this important technological development to my patients.”
In the USA, millions of orthopedic surgeries are performed each year in hospitals and ambulatory surgical centers, and the majority of these procedures utilize radiography. The now-510(k) cleared PhantomMSK™ System currently provides assistance in multiple procedures, including the fast-growing direct anterior approach total hip arthroplasty surgery, where it aims to help restore native hip biomechanics with alignment considerations for leg length, femoral offset, cup inclination, femoral abduction, pelvic tilt, and pelvic obliquity.
“Adding the PhantomMSK™ System to our portfolio of solutions with this critical 510(k) clearance represents a new era for the company, and we expect to reach thousands of orthopedic physicians this year with deliberate education that highlights the science and benefits associated with our unique and patented distortion adaptation technology, added OrthoGrid Co-CEO, Richard Boddington. We invite any interested clinicians to visit us at the 2019 American Academy of Orthopedic Surgeons (AAOS) meeting where we will be providing daily demonstrations in booth #625.
About OrthoGrid Systems, Inc.
OrthoGrid Systems is a rapidly expanding global leader in intraoperative imaging technologies targeting component and anatomic alignment, imaging efficiency, optimized visualization and decision-making support for orthopedic surgery. OrthoGrid specializes in leveraging the latest innovation in technology to create practical and efficient solutions available or in development for hip arthroplasty, hip preservation, trauma and other standard procedures performed over 10 million times per year globally. Learn more about OrthoGrid and our products by visiting our website at www.orthogrid.com.
Source: OrthoGrid Systems, Inc.
Media Contact: Edouard Saget, Co-CEO
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