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

Rhea-AI Summary

Zimmer Biomet (NYSE: ZBH) has received FDA 510(k) clearance for its OsseoFit™ Stemless Shoulder System for total shoulder replacement. The innovative implant features an anatomically shaped design that matches natural humeral anatomy while preserving healthy bone. The system integrates with Identity® Humeral Heads and Alliance® Glenoid, offering versatile options for patient-specific needs.

Key features include left-or-right-sided anchor implants with fins for press-fit insertion, fully porous windows, and anterior reattachment suture holes. The system comes in a single instrument tray for efficient workflow. Commercial availability is scheduled for Q1 2025.

Positive

• FDA 510(k) clearance obtained for new shoulder replacement system
• Integration with existing product lines enhances portfolio offering
• Design features support bone preservation and stable fixation
• Streamlined single-tray system suitable for various surgical settings

Negative

• Commercial launch delayed until Q1 2025

Insights

Medical Device Analyst

The FDA clearance of the OsseoFit™ Stemless Shoulder System represents a significant advancement in Zimmer Biomet's orthopedic portfolio. The system's innovative design, featuring anatomically shaped asymmetric implants and OsseoTi® Porous Metal Technology, addresses key market demands for bone preservation and improved surgical outcomes. The technology's compatibility with existing Zimmer Biomet products (Identity® Humeral Heads and Alliance® Glenoid) strengthens the company's competitive position in the $1.9 billion global shoulder replacement market. The Q1 2025 commercial launch timing provides a clear catalyst for revenue growth, while the system's suitability for ambulatory surgical centers aligns with the industry shift toward outpatient procedures, potentially expanding market reach and adoption.

Market Research Analyst

This FDA clearance strategically positions Zimmer Biomet to capture a larger share of the growing shoulder arthroplasty market, particularly among younger patients requiring joint replacement. The product's bone-preserving design addresses a critical market need, as the average age for shoulder replacement procedures continues to decrease. The single-tray instrument system and ambulatory surgical center compatibility align with healthcare efficiency trends and cost-containment initiatives. The endorsement from Mayo Clinic adds significant credibility and could accelerate market adoption. This launch could help ZBH maintain its leadership position in orthopedics and potentially drive market share gains in the shoulder segment.

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.

Media		Investors
Heather Zoumas-Lubeski 445-248-0577 heather.zoumaslubeski@zimmerbiomet.com		David DeMartino 646-531-6115 david.demartino@zimmerbiomet.com
Kirsten Fallon 781-779-5561 kirsten.fallon@zimmerbiomet.com		Zach Weiner  908-591-6955  zach.weiner@zimmerbiomet.com

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SOURCE Zimmer Biomet Holdings, Inc.

FAQ

When will Zimmer Biomet's OsseoFit Stemless Shoulder System (ZBH) be commercially available?

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

What FDA clearance did Zimmer Biomet (ZBH) receive for its shoulder system?

Zimmer Biomet received FDA 510(k) clearance for the OsseoFit Stemless Shoulder System for total shoulder replacement.

What are the key features of ZBH's new OsseoFit Stemless Shoulder System?

The system features anatomically shaped left-or-right-sided anchor implants with fins for press-fit insertion, fully porous windows, and anterior reattachment suture holes, designed to match natural humeral anatomy while preserving healthy bone.

Which existing Zimmer Biomet products is the OsseoFit system compatible with?

The OsseoFit system integrates with Identity® Humeral Heads with Versa-Dial® Technology and the Alliance® Glenoid system.

How does the OsseoFit system (ZBH) improve surgical workflow efficiency?

The system comes in a singular instrument tray to maximize workflow and sterile process efficiency, making it suitable for various settings including ambulatory surgical centers.