LEESBURG, Va., Sept. 3, 2015 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc. (Nasdaq:KTWO) (the "Company" or "K2M"), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced it has 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 the family of PYRENEES products. In addition to U.S. regulatory clearance, K2M also received a CE Mark for the system, which allows the Company to expand the global availability of the product.
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," stated Dr. Mina Foroohar, neurosurgeon and president of Northwest Neurosurgery Institute in Arlington Heights, Illinois.
Dr. Douglas B. Moreland, neurosurgeon and clinical assistant professor of neurosurgery at the University at Buffalo in New York state, 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. 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 tifix® Locking 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 PYRENESS family, as it provides yet another option for surgeons addressing cervical fixation of the spine."
The PYRENESS 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.
For more information on the PYRENEES Mono Cervical Plate System and K2M's complete product portfolio, visit www.K2M.com.
K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the Company to favorably compete in the global spinal surgery market. Additional information is available online at www.K2M.com.
This press release contains forward-looking statements that reflect our current views with respect to, among other things, our operations and financial performance. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as "outlook," "believes," "expects," "potential," "continues," "may," "will," "should," "could," "seeks," "predicts," "intends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. 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Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.
We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.
The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward looking statements and you should not place undue reliance on our forward-looking statements.
Media ContactZeno Group on behalf of K2M Group Holdings, Inc.Marcie Kohenak, 202-965-7811