WARSAW,
Ind., Sept. 20, 2022 /PRNewswire/ -- Zimmer
Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical
technology leader, today announced U.S. Food and Drug
Administration (FDA) 510(k) clearance of the Identity™ Shoulder
System for anatomic, reverse and revision shoulder replacement. The
Identity Shoulder System is a convertible system that uses
proprietary technologies to align each surgeon's approach to an
individual patient's anatomy, with the goal of alleviating pain and
optimizing range of motion. The latest addition to Zimmer Biomet's
portfolio of shoulder replacement systems, the Identity Shoulder
System is designed to allow surgeons to devise and execute a
patient-specific surgical plan with precision.
![(PRNewsfoto/Zimmer Biomet Holdings, Inc.) (PRNewsfoto/Zimmer Biomet Holdings, Inc.)](https://mma.prnewswire.com/media/1603977/Zimmer_Biomet_Holdings_Logo.jpg)
"The FDA clearance of the Identity Shoulder System is exciting
because it offers surgeons a highly adaptable solution for
anatomic, reverse and revision procedures to help patients optimize
natural shoulder movement," said Ivan Tornos, Chief Operating
Officer at Zimmer Biomet. "This significant milestone adds to
progress in our growing Sports Medicine, Extremities and Trauma
(S.E.T.) portfolio, a critical area of focus as we expand our
position as a global leader in innovative medical technologies that
maximize mobility."
The Identity Shoulder System expands on the traditional inlay
and onlay1 reconstruction used in reverse shoulder
arthroplasty by providing eight humeral tray combinations that give
surgeons increased options for aligning the humerus (upper arm
bone) with the glenoid (shoulder socket), without lengthening the
arm. Designed to offer adaptability for potential revision
procedures in the future, the Identity Shoulder System allows for
5mm of additional joint space below resection2, which
gives surgeons more to work with if a revision is needed in the
future.
Similar to all shoulder systems in Zimmer Biomet's portfolio,
the Identity Shoulder System utilizes proprietary technologies,
including Versa-Dial® for infinite humeral head offset
placement and Alliance® Glenoid for a broad range of
glenoid options, to adapt to a patient's unique anatomy.
"The Identity Shoulder System was designed to help surgeons
restore center of rotation and achieve optimal range of motion
after reverse shoulder replacements, a main goal of these
procedures," said William N. Levine,
M.D., Chair of the Department of Orthopedic Surgery at Columbia University's College of Physicians and
Surgeons, and a member of the Identity Shoulder System
development team. "Shoulder specialists will value this system's
adaptability and flexibility to support their unique surgical
approaches and complement diverse patient anatomies."
This new system expands Zimmer Biomet's upper extremities
portfolio, which includes the Comprehensive® Nano
Stemless Shoulder and the Signature™ ONE Surgical Planning System,
part of the ZBEdge Shoulder ecosystem. For more information about
the Identity™ Shoulder System, visit
www.zimmerbiomet.com/en/products-and-solutions/specialties/shoulder/identity-shoulder-system.html.
About Zimmer Biomet
Zimmer Biomet is a global medical technology leader
with a comprehensive portfolio designed to maximize mobility and
improve health. We seamlessly transform the patient experience
through our innovative products and suite of integrated digital and
robotic technologies that leverage data, data analytics and
artificial intelligence.
With 90+ years of trusted leadership and proven expertise,
Zimmer Biomet is positioned to deliver the highest quality
solutions to patients and providers. Our legacy continues to
come to life today through our progressive culture of evolution and
innovation.
For more information about our product portfolio, our operations
in 25+ countries and sales in 100+ countries or about joining our
team, visit www.zimmerbiomet.com or follow Zimmer Biomet
on Twitter at www.twitter.com/zimmerbiomet.
Cautionary Statement Regarding
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include,
but are not limited to, statements concerning Zimmer Biomet's
expectations, plans, prospects, and product and service offerings,
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, uncertainties
and changes in circumstances that could cause actual outcomes and
results to differ materially. For a list and description of some of
such risks and uncertainties, see Zimmer Biomet's periodic reports
filed with the U.S. Securities and Exchange Commission
(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.
Forward-looking statements speak only as of the date they are made,
and Zimmer Biomet disclaims any intention or obligation to update
or revise any forward-looking statements, whether as a result of
new information, future events or otherwise. Readers of this news
release are cautioned not to rely on these forward-looking
statements, since 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 news release.
Media
Meredith
Weissman
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Investors
Keri Mattox
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703-346-3127
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215-275-2431
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meredith.weissman@zimmerbiomet.com
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keri.mattox@zimmerbiomet.com
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1 Inlay and
onlay are two different reverse shoulder prosthesis designs. The
inlay design is implanted centrally on the humerus (upper arm bone)
to match the surrounding anatomy with a fit that leaves it flush
with the surrounding cartilage. An onlay design rests above the
anatomic neck resection.
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2 Compared
to Comprehensive® Total Shoulder system.
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SOURCE Zimmer Biomet Holdings, Inc.