Zimmer Biomet Receives FDA Clearance for Persona® SoluTion™ PPS® Femur

Rhea-AI Summary

Zimmer Biomet (NYSE: ZBH) has received FDA 510(k) clearance for its Persona® SoluTion™ PPS® Femur, a total knee implant component designed for patients with sensitivities to bone cement and/or metal. The implant features a porous coating for cementless fixation and a proprietary surface treatment for enhanced wear performance.

The device, when combined with Persona OsseoTi® Tibia and OsseoTi Patella, offers a fully cementless alternative to cobalt-chrome implants. Made of Tivanium® alloy, it minimizes common metal sensitizers and demonstrates similar wear performance compared to traditional cobalt chromium alloy components. Commercial availability in the U.S. is expected in Q1 2025.

Positive

• FDA 510(k) clearance received for new total knee implant component
• Addresses market need for patients with metal/cement sensitivities
• Provides fully cementless alternative to traditional implants
• Commercial launch planned for Q1 2025

Negative

• None.

Insights

Medical Research Analyst

This FDA clearance represents a significant advancement in total knee replacement technology. The Persona SoluTion PPS Femur addresses two critical issues in knee arthroplasty: metal sensitivity and cement-related complications. The product's innovative features include:

• Porous coating for cementless fixation
• Proprietary Tivanium alloy with reduced metal sensitizers
• Ti-Nidium Surface Hardening Process for enhanced wear performance

The clinical significance lies in proactively addressing revision surgeries caused by metal and cement sensitivities. The wear performance data showing comparable results to traditional cobalt-chromium implants while reducing sensitivity risks is particularly noteworthy. With commercial availability in Q1 2025, this product could help reduce revision rates and improve patient outcomes in the $8.5 billion global knee replacement market.

Financial Analyst

This FDA clearance strengthens Zimmer Biomet's competitive position in the knee replacement market. The timing is strategic as the aging population drives increased demand for joint replacements. Key financial implications include:

• Potential market share gains in the premium implant segment
• Higher margins compared to traditional implants
• Reduced liability risks from complications

The product differentiates ZBH from competitors by addressing specific patient needs and could drive revenue growth in 2025 and beyond. The company's strong market position, with a $22 billion market cap, combined with this innovative product launch, positions it well for continued growth in the orthopedic space.

A Total Knee Replacement Alternative for Patients with Metal and/or Bone Cement Sensitivities

WARSAW, Ind., Dec. 4, 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 of Persona^® SoluTion™ Porous Plasma Spray (PPS^®) Femur, a total knee implant component offering an alternative for patients with sensitivities to bone cement and/or metal. The Persona SoluTion PPS Femur features a porous coating for cementless fixation and leverages a proprietary surface treatment designed to enhance wear performance.^1,2

"With the FDA clearance of Persona SoluTion PPS Femur, in combination with our Persona OsseoTi^® Tibia and OsseoTi Patella, we are proud to offer surgeons a fully cementless alternative to cobalt-chrome implants," said Joe Urban, President, Knees at Zimmer Biomet. "Persona SoluTion PPS Femur combines our latest advances in cementless fixation with decades of proprietary clinical expertise in developing novel materials and surface hardening processes. The utility and versatility of our comprehensive and clinically proven Persona Knee System is further enhanced with the addition of this innovative solution that could help surgeons address two potential causes of revision procedures: sensitivities to bone cement and metal."

"Hypersensitivities to bone cement or certain metals in implants are often not identified until after surgery when the patient reports pain and other signs of implant loosening," said Dr. George Guild III, MD of Total Joint Specialists in Cumming, Georgia. "With the availability of this option, surgeons can proactively mitigate a potentially avoidable risk of implant failure."

Hypersensitivity to metal is a challenge for a certain patient population associated with a traditional cemented total knee replacement (TKR) with an implant made of cobalt-chrome (Co-Cr-Mo) alloy.³ When exposed to certain metals, people with these hypersensitivities can experience an inflammatory response, pain and implant loosening that can require a revision TKR.⁴ Persona SoluTion PPS Femur offers cementless fixation with its clinically proven PPS coating that provides initial scratch fit stability and supports biologic fixation through bony ongrowth.^3-12 When combined with Persona OsseoTi tibia and Vivacit-E^® Highly Crosslinked Polyethylene (HXLPE), the total knee implant is designed to minimize the most common metal sensitizers (nickel, cobalt and chromium) likely to elicit an immune response and is made of a proprietary Tivanium^® (Ti-6Al-4V) alloy with over 17 years of clinical use.¹³ The Tivanium alloy is treated with the Ti-Nidium Surface Hardening Process and is compatible with Vivacit-E HXLPE articular surfaces. The Persona Solution PPS femur coupled with a Vivacit-E bearing demonstrates similar wear performance as compared to Persona cobalt chromium alloy femur coupled with a Vivacit-E bearing.^14,15

Persona SoluTion PPS Femur will be commercially available in the U.S. in Q1 2025.

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, product benefits 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:

1. Improved Abrasion Resistance of Nitrogen-Hardened Titanium Alloy Surfaces. Current Topics in Orthopaedic Technology. Zimmer. Vol. 3, No. 6 (1991).
2. Zimmer ZRR_WA_2537_12
3. Akil S, Newman JM, Shah NV, Ahmed N, Deshmukh AJ, Maheshwari AV. Metal hypersensitivity in total hip and knee arthroplasty: Current concepts. J Clin Orthop Trauma. 2018 Jan-Mar;9(1):3-6, 2018.
4. Hozack, W. et al. Primary Cementless Hip Arthroplasty with a Titanium Plasma Sprayed Prosthesis. Clinical Orthopaedics and Related Research. 333: 217-25, 1996.
5. Head, W. et al. A Titanium Cementless Calcar Replacement Prosthesis in Revision Surgery of the Femur: 13 Year Experience. Journal of Arthroplasty. 16(8): 183-7, 2001.
6. Head, W. et al. The Proximal Porous Coating Alternative for Primary Arthroplasty. Orthopedics. 22(9): 813-5, 1999.
7. Keisu, K. et al. Primary Cementless Total Hip Arthroplasty in Octogenarians: Two to Eleven Year Follow-up. Journal of Bone and Joint Surgery. 83: 359, 2001.
8. McLaughlin, J. et al. Total Hip Arthroplasty in Young Patients. 8 to 13 Year Results Using an Uncemented Stem. Clinical Orthopaedics and Related Research. 373: 152-63, 2000.
9. Parvizi, J. et al. Prospective Matched-Pair Analysis of Hydroxyapatite- Coated and Uncoated Femoral Stems in Total Hip Arthroplasty. Journal of Bone and Joint Surgery. 83: 783-6, 2004.
10. McLaughlin, J. et al. Total Hip Arthroplasty with an Uncemented Femoral Component. A Long Term study of the Taperloc Stem. Journal of Arthroplasty. 19(2): 151-6, 2004.
11. Meding, K. et al. Minimum Ten-Year Follow-up of a Straight- Stemmed, Plasma-Sprayed, Titanium-Alloy, Uncemented Femoral Component in Primary Total Hip Arthroplasty. Journal of Bone and Joint Surgery. 86: 92-7, 2004
12. McLaughlin, J.R., et al. Long-term results of uncemented total hip arthoplasty with the Taperloc femoral component in patients with Dorr type C proximal femoral morphology. The Bone & Joint Journal 2016; 98-B:595-600
13. Rossi SMP, Perticarini L, Mosconi M, Ghiara M, Benazzo F. Ten-year outcomes of a nitrided Ti-6Al-4V titanium alloy fixed-bearing total knee replacement with a highly crosslinked polyethylene-bearing in patients with metal allergy. The Knee. 2020;27(5):1519-1524.
14. ZRR_WA_3118_19
15. ZRR_WA_3135_20 

Media   Heather Zoumas-Lubeski 445-248-0577 heather.zoumaslubeski@zimmerbiomet.com   Kirsten Fallon 781-779-5561 kirsten.fallon@zimmerbiomet.com

Investors David DeMartino 646-531-6115 david.demartino@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 Persona SoluTion PPS Femur be available commercially?

The Persona SoluTion PPS Femur will be commercially available in the United States in Q1 2025.

What is the main benefit of ZBH's new Persona SoluTion PPS Femur implant?

The implant provides an alternative for patients with sensitivities to bone cement and/or metal, featuring cementless fixation and minimizing common metal sensitizers.

What regulatory approval did Zimmer Biomet (ZBH) receive for the Persona SoluTion PPS Femur?

Zimmer Biomet received FDA 510(k) clearance for the Persona SoluTion PPS Femur on December 4, 2024.

How does the wear performance of ZBH's Persona SoluTion PPS Femur compare to traditional implants?

When coupled with a Vivacit-E bearing, it demonstrates similar wear performance compared to Persona cobalt chromium alloy femur components.