OrthoGrid Systems Receives FDA 510(K) Clearance for PhantomMSK Trauma Application

OrthoGrid Systems announces its newest application, PhantomMSK Trauma, has received 510(K) clearance from the U.S. Food and Drug Administration (FDA).

OrthoGrid Systems' PhantomMSK is a universal software platform that works with all manufacturer devices across multiple procedures to assist with implant, instrument and anatomic alignment that use fluoroscopic imaging. It is the only intraoperative alignment technology on the market to correct the phenomenon of image distortion in orthopedic surgery, attributed to external electromagnetic interference and the mapping of the planar image on a curved input phosphor, affecting image integrity and causing potential risks of malalignment.

The new Trauma application joins several others on the PhantomMSK platform, including the Hip and Hip Preservation applications that contribute to improved surgical accuracy and efficiency, leading to better patient outcomes.

The PhantomMSK Trauma application uses software features in conjunction with proprietary algorithms to correct fluoroscopic image distortion. To operate PhantomMSK Trauma, a fluoroscopic image is acquired from a C-arm displayed outside the sterile field, where the image analysis tools can be used at the surgeon's discretion. OrthoGrid's intelligence-guided systems are designed to work within the surgical theater flow and interface with existing hospital equipment leading to greater precision and contributing to reduced hospital re-admissions.

"This milestone represents years of scientific research and data, product development and our commitment to empowering surgeons in the OR with advanced decision support tools," said Edouard Saget, co-founder and CEO of OrthoGrid Systems.

"We will continue to innovate in the market by using emerging technologies in an effort to drive value-based care that benefits patients, hospitals, and surgeons," said co-founder and CEO of OrthoGrid Systems, Richard Boddington.

The PhantomMSK Trauma application will be available in Spring 2020.

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