Zimmer Biomet Receives FDA Clearance for OsseoFit™ Stemless Shoulder System for Total Shoulder Replacement

New Anatomically Shaped Asymmetric Stemless Design for Total Shoulder Replacement

WARSAW, Ind., Dec. 13, 2024 /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 for the OsseoFit™ Stemless Shoulder System for total shoulder replacement. This innovative implant is designed to match the natural humeral (upper shoulder bone) anatomy^1-3 to optimize anatomical fit while maximizing preservation of healthy bone. The OsseoFit Stemless Shoulder System expands the company’s expansive total shoulder portfolio and integrates with Identity^® Humeral Heads with Versa-Dial^® Technology for infinite offset placement as well as the Alliance^® Glenoid for a broad range of glenoid options to adapt to a patient’s unique anatomy.

“The OsseoFit Stemless Shoulder System combines an anatomically shaped implant^1-3 which supports bone conservation and is designed for stable initial fixation^4-7, with our proprietary OsseoTi^® Porous Metal Technology for biological fixation,”^8,9* said Brian Hatcher, President, SET & CMFT at Zimmer Biomet. “We are pleased to offer OsseoFit within our robust shoulder portfolio that includes modular, compatible components which provide surgeons with a multitude of options based on patients’ unique anatomy while maintaining a small instrument footprint and maximizing workflow efficiency.”

The anatomically designed left- or-right-sided anchor implants feature fins which create a press-fit during insertion and contain fully porous windows. The fin geometry and anchor spacing of the implant determine proper orientation and fit^1-3 into the natural bone and help avoid cortical impingement, while reaching dense bone areas.^2,3,10 In addition, the design includes strategically located anterior reattachment suture holes on the anchor to facilitate subscapularis repair. The system is available in a singular instrument tray to maximize workflow, and sterile process efficiency, to fit nicely in a variety of settings including ambulatory surgical centers.

“As younger and more active patients require shoulder replacements, bone preservation becomes increasingly critical to accommodate potential revision procedures in the future,” said John W. Sperling, MD, MBA, Professor of Orthopedic Surgery at Mayo Clinic, and a member of the OsseoFit Stemless Shoulder System surgeon development team. “Using a method that mimics the asymmetry of the natural humerus enables surgeons to preserve native bone while optimizing fixation.”

The OsseoFit Stemless Shoulder will be commercially available in Q1 2025.

Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.

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 on LinkedIn at www.linkedin.com/company/zimmerbiomet or X / 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.

References

*Animal Studies are not necessarily indicative of clinical performance.

1. Mueri, C., Snethen, K., Parisi, R., Son, Yang., Duquin, T. Characterization of the Asymmetric Bone Envelope of the Proximal Humeral Metaphysis for Stemless Shoulder Implants. Accepted for presentation at the ORS Orthopaedic Research Society 2025 Annual Meeting; 2025 Feb 7-11; Phoenix, Arizona.
2. Son, Y, Mueri, C., Snethen, K., Bowman, L., Parisi, R., Duquin, T. Optimizing Stemless Humeral Anchors: Asymmetrical Designs for Minimizing Cortical Bone Impingement while Maximizing Cancellous Bone Purchase. Accepted for presentation at the ORS Orthopaedic Research Society 2025 Annual Meeting; 2025 Feb 7-11; Phoenix, Arizona.
3. ZRR_WI_6743_24. Zimmer Biomet Internal Research Report on File.
4. Snethen, K., Mueri, C., Kriska, T., Son, Y., Bandi, M. The Sensitivity of the Stability of Stemless Humeral Implants to Surgical, Patient and Design Factors in Reverse Shoulder Arthroplasty. Presented at the ORS Orthopaedic Research Society Annual Meeting; 2023, Dallas, Texas.
5. Snethen, K., Son, Y., Mueri, C., Bischoff, J. The Effect of Press-fit on Initial Stability in Stemless Shoulder Arthroplasty. Presented at the ISTA International Society for Technology in Arthroplasty Annual Meeting; 2022, Maui, Hawaii.
6. Snethen, K., Mueri, C., Son, Y., Parisi, R., Duquin, T. The Effect of Geometric Design on Initial Stability of Stemless. Accepted for presentation at the ORS Orthopaedic Research Society 2025 Annual Meeting; 2025 Feb 7-11; Phoenix, Arizona.
7. ZBTR_30118. Zimmer Biomet Internal Research Report on File.
8. OsseoTi Porous Metal Technology uses anatomical data in combination with 3D printing technology to build a structure designed to mimic the architecture of human cancellous – or spongey - bone.
9. Gupta, G. Evaluation of Bony Ingrowth Implant Materials in an In Vivo Sheep Long Bone Defect Model 12-04/12-07, February 2013. 32.
10. Hamidreza Alidousti, Joshua W Giles, Roger J H Emery, Jonathan Jeffers, Spatial mapping of humeral head bone density, Journal of Shoulder and Elbow Surgery 2017, Vol 26, 1653-1661.

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SOURCE Zimmer Biomet Holdings, Inc.