The FDA granted OrthoGrid Systems' PhantomMSK Orthopedic Platform 510(k) clearance.
Three things to know:
1. As a result of the FDA clearance, OrthoGrid plans to launch a national educational campaign about the importance of recognizing and correcting for fluoroscopic 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," said orthopedic surgeon John Masonis, MD.
2. Its PhantomMSK System is designed to assist in direct anterior approach total hip arthroplasty surgery, where it is intended to help restore native hip biomechanics with alignment considerations for leg length, femoral offset, cup inclination, femoral abduction, pelvic tilt and pelvic obliquity.
3. OrthoGrid is an intraoperative imaging technology company focused on orthopedics.