Zimmer Biomet Receives FDA Clearance for Identity™ Shoulder System for Shoulder Replacement

Rhea-AI Summary

Zimmer Biomet (ZBH) announced FDA 510(k) clearance for its Identity™ Shoulder System, designed for anatomic, reverse, and revision shoulder replacements. This system allows surgeons to tailor surgical plans to individual patient anatomy, aiming to enhance pain relief and range of motion. The innovative design provides eight humeral tray combinations and 5mm additional joint space for possible future revisions. With this clearance, Zimmer Biomet strengthens its Sports Medicine and Extremities portfolio, reinforcing its position as a leader in medical technology.

Positive

• FDA clearance for Identity Shoulder System enhances ZBH's portfolio.
• System allows for tailored surgical planning to improve patient outcomes.
• Introduces eight humeral tray combinations for personalized procedures.
• Increases potential for future revision procedures with additional joint space.

Negative

• None.

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.

"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		Investors Keri Mattox
703-346-3127		215-275-2431
meredith.weissman@zimmerbiomet.com		keri.mattox@zimmerbiomet.com

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.

2 Compared to Comprehensive® Total Shoulder system.

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SOURCE Zimmer Biomet Holdings, Inc.

FAQ

What is the Identity Shoulder System by Zimmer Biomet?

The Identity Shoulder System is a shoulder replacement system designed for anatomic, reverse, and revision surgeries, allowing for personalized surgical plans.

When was the Identity Shoulder System cleared by the FDA?

The Identity Shoulder System received FDA 510(k) clearance on September 20, 2022.

What are the benefits of the Identity Shoulder System?

The system offers adaptability for unique patient anatomies and enhances surgical precision, contributing to improved mobility and pain relief.

How does the Identity Shoulder System impact future revisions?

It allows for an additional 5mm of joint space, facilitating potential revisions if needed in the future.

What company does the Identity Shoulder System belong to?

The Identity Shoulder System is a product of Zimmer Biomet Holdings, Inc. (ZBH).