OrthoGrid Systems Gains FDA Clearance for Trauma Surgical Imaging Application

By Julie A. Vetalice

OrthoGrid Systems received FDA 510(k) clearance to market a PhantomMSK Trauma application for intraoperative surgical imaging. The new application will be available in Spring 2020.

PhantomMSK software works with all manufacturer devices to assist with implant, instrument and anatomic alignments that use fluoroscopic imaging. It is reportedly the only intraoperative alignment technology to correct fluoroscopic image distortion in orthopedic surgery.

The software uses a fluoroscopic image is acquired from a C-arm outside the sterile field. OrthoGrid's intelligence-guided systems work within the surgical theater flow with existing hospital equipment.

The trauma application joins OrthoGrid's Hip and Hip Preservation applications for the PhantomMSK platform that contributes to improved surgical accuracy and efficiency.

Product Labels: Surgical Navigation

Tags: 510(k) Clearance, Regulatory