K2M Gets FDA OK and CE Mark for New Cervical Plate System

Spine implant firm K2M Group Holdings Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Pyrenees Mono Cervical Plate System, the company’s latest addition to its Pyrenees line of products. In addition to U.S. regulatory clearance, K2M also received a CE mark for the system.

According to the company, the Pyrenees Mono Cervical Plate System offers a “slim-profile design that allows for a single point of fixation per level for improved visualization in-situ.” The posterior profile of the plate is designed to reduce plate migration in-situ during screw insertion. With screws manufactured from titanium alloy and plates manufactured from commercially pure grade II titanium, the system includes one- and two-level plates.

“Compared to a traditional two hole plate, the [Pyrenees Mono Plate’s] narrow profile offers easier use while working under a microscope and provides me with an opportunity to perform less lateral retraction than a wider cervical plate,” said Mina Foroohar, M.D., neurosurgeon and president of Northwest Neurosurgery Institute in Arlington Heights, Ill.

The Pyrenees Mono Cervical Plate System is the third offering in the Pyrenees family of cervical plates, which also includes the Pyrenees Constrained Cervical Plate System and the Pyrenees Translational Cervical Plate System.

Douglas B. Moreland, M.D., neurosurgeon and clinical assistant professor of neurosurgery at the University at Buffalo in New York, added, “The Pyrenees Mono Plate is very user friendly, as the plate is smaller and requires only one screw per level, which has allowed me to save time during both vertebral body prep for the plate and screw placement.”

Pyrenees Mono Cervical Plates do not have bend zones, allowing for precise plate contouring, company officials said. The plates are designed with lordotic curvature to minimize intraoperative contouring, and all plates can be bent anatomically without compromising the ability of the screws to lock at any angle. Featuring K2M’s revolutionary TifixLocking Technology, the Pyrenees Mono Cervical Plate System does not require an additional locking mechanism, as each screw head forms an autogenic lock to the plate upon insertion.

“We are excited to receive regulatory clearance and a CE mark for our Pyrenees Mono Cervical Plate System, and have received positive surgeon feedback following the completion of the first surgical cases,” stated Eric Major, K2M’s president and CEO. “This latest addition to our degenerative portfolio is an important extension of our Pyrenees family, as it provides yet another option for surgeons addressing cervical fixation of the spine.”

K2M is based in Leesburg, Va.