Saturday, March 12, 2016

News: Zimmer Biomet Announces FDA Clearance for Compatibility of Nexel™ Total Elbow and Comprehensive® Segmental Revision System

Compatibility of proximal, distal and total humeral replacement system with total elbow system becomes first Zimmer Biomet FDA submission and clearance involving two separate systems


ZIMMER BIOMET INC. LOGO
WARSAW, Ind., March 3, 2016 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, is pleased to announce that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the compatibility of the Nexel™ Total Elbow System with the Comprehensive® Segmental Revision System (SRS).  This 510(k) clearance marks the first submission by the Company to establish the compatibility of two separate Zimmer Biomet implant systems.  The distal component of the Comprehensive SRS humeral system when combined with the Nexel Total Elbow System is designed for elbow replacement, while the remaining components allow for proximal or total humeral reconstruction when used with the glenoid component of the Comprehensive Shoulder System.

"The ability to link the clinically proven Comprehensive SRS system with a reliable total elbow system like the Nexel provides surgeons with multiple strategies to treat patients with excessive bone loss at the distal humerus," said Dr. Peter J. Evans, Director of the Upper Extremity Center at the Cleveland Clinic.  "The straightforward and efficient instrumentation of both systems also facilitates proper humeral and ulnar length, as well as soft tissue tension."
In addition to addressing proximal, distal or complete humeral replacement, the ability of the Comprehensive SRS and Nexel Total Elbow to interact with the Regenerex™ Tissue Attachment Augments addresses concerns regarding graft availability and resorption as well as providing tissue stabilization and attachment points.
"The compatibility of the Comprehensive SRS system with the Nexel Total Elbow is another example of how the combined Zimmer Biomet Extremities portfolio supports surgeons in addressing difficult revision, deformity and fracture cases," said Orsa Britton, Vice President & General Manager of the global Extremities business.  "Our commercial teams are very excited about the opportunities signaled by this recent FDA clearance, as well as the ongoing opportunity to meet our Customers' needs with our market-leading, broad and innovative range of Extremities solutions."
For more information on the Comprehensive SRS and Nexel Total Elbow, contact your Zimmer Biomet Sales Representative or visit zimmerbiomet.com.
About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone healing, craniomaxillofacial and thoracic products; dental implants; and related surgical products.
We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.
We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit zimmerbiomet.com or follow Zimmer Biomet on Twitter at twitter.com/zimmerbiomet.
Cautionary Statement Regarding Forward-Looking Statements
This communication contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements may be identified by the use of forward-looking terms such as "may," "will," "expects," "believes," "aims," "anticipates," "plans," "estimates," "projects," "assumes," "guides," "targets," "forecasts," and "seeks" or the negatives of such terms or other variations on such terms or comparable terminology.  Forward-looking statements include, but are not limited to, statements concerning products and services offered by Zimmer Biomet, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet's filings with the SEC.  We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this communication are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this communication.
Published at PR NewsWire

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