The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to a 3D optical navigation system for spine surgery.
According to the FDA 510(k) summary document, the device is a “stereotaxic image guidance system intended for the spatial positioning and orientation of surgical instruments used by orthopedic surgeons and neurosurgeons during posterior approach spinal fusion surgeries when pre-operative CT imagery is available.”
The system, along with its “spine surgery planning and navigation software and 3D optical camera, is intended as an aid for precisely locating anatomical structures in posterior approach open spine fusion surgery during pedicle screw placement in the thoraco-lumbo-sacral region.”
Additionally, the device is indicated for “posterior approach open spine fusion surgery during pedicle screw placement in the thoracolumbo-sacral region where reference to a rigid anatomical structure can be identified.”
In order to qualify for the shorter and earlier 510(k) clearance the device must be substantially equivalent to a predicate device which, in this case, was 7D Surgical’s (now part of Orthofix/SeaSpine) Envision 3D™: Image Guidance System. 7D Surgical’s system and the predicate device have similar indications for use and primary intended uses.
The new navigation system is brand names ‘PathKeeper’ and one user, Tushar Patel, M.D. of Washington Orthopaedics & Sports Medicine, offered these comments in support of the newly cleared system: “There is a definite need for a new navigation system that is adaptable and easily integrated into operating rooms. PathKeeper took that challenge and created a spine navigation system that is easily operated, offers real-time tracking and eliminates radiation exposure during the procedure.”
In Dr. Patel’s opinion, “the PathKeeper system is a new standard of care.”
Israel-based PathKeeper Surgical LTD is the developer of the system and submitted the 510(k) application.
PathKeeper Chief Executive Officer and Founder Erez Lampert said, “We are excited to reach this important milestone for PathKeeper and the company. We now move our focus to commercialization in the United States to make PathKeeper available to all spine surgeons and their patients.”
