SpineFrontier Releases New Pedicle Screw System

SpineFrontier Inc. has released the Pedfuse Remind pedicle screw system for midline lumbar surgery. Kingsley Chin, M.D., SpineFrontier founder and CEO, explained that his company’s technology is designed for “less-exposure surgery (LES),” which is a philosophy of using “proportionate exposure for maximal effectiveness, to preserve the anatomy, diminish blood loss, surgical time, and exposure to radiation.” The system was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) in February.

“The Remind LES screw is another testament to the technologies driven by the LES philosophy that we as surgeons can easily adopt and that allow for maximally effective treatments with minimal tissue disruption,” said Chin.

The Pedfuse Remind pedicle screw system is an LES technology that provides immobilization and stabilization of spinal segments as an adjunct to fusion. The system includes a Quad H screw that has a thread designed to optimize its grip on cortical (compact, denser bone) and cancellous (spongy) bone, reportedly allowing it to advance with half the turns of a standard screw.

“The Remind LES Screw is ideal for surgeons who prefer pedicle screws over other technologies like Facetfuse screws, but who want to perform LES techniques,” said Chin. “Placing the LES screw through the pars [a section of bone located in the vertebrae] and fixating the pedicle using a mediolateral trajectory, versus starting from the traditional point lateral to the facets, means a standard midline incision with minimal tissue retraction is all we need. The new Quad H Cortican thread technology design provides stronger fixation in the cortical pars bone as well as within the pedicle and vertebral body. Other advantages of the screw include less likelihood of hardware irritation of the muscles, avoidance of the adjacent facet capsule, and the opportunity for the surgeon to place bone graft along the retained facets and lamina for fusion.”

In August last year, SpineFrontier was reprimanded by the FDA for inadequate reporting of adverse events related to its devices. According to the agency, a device in the company’s Pedfuse portfolio was associated with the death of a patient in 2011, and the company failed to report the event. In 2012, two more device malfunctions occurred and SpineFrontier did not report the events in time. The FDA said it was concerned that the company’s personnel are not adequately trained to identify events that are reportable to the agency.

SpineFrontier makes spine surgery devices, and is headquartered in Beverly, Mass.