Dec 4, 2024   SOURCE: PR NewsWire

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

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(TM) 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:

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    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



     
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     Heather Zoumas-Lubeski                            
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SOURCE Zimmer Biomet Holdings, Inc.