Zimmer Biomet Receives FDA Clearance for Persona® Revision SoluTion™ Femur
Zimmer Biomet (NYSE: ZBH) has received FDA 510(k) clearance for its Persona® Revision SoluTion™ Femur, a revolutionary revision knee implant designed for patients with metal sensitivities. The implant is part of the comprehensive Persona Revision Knee System and features a proprietary surface-hardening treatment for enhanced wear performance.
The innovation addresses a significant medical need, as metal hypersensitivity affects 10-15% of the general population and up to 25% of patients with metallic implants. The implant is made exclusively from Tivanium® alloy with the Ti-Nidium Surface Hardening Process, offering an alternative free from common metal allergens like Nickel, Cobalt, and Chromium.
The product will be available commercially in the U.S. in Q3 2025, offering standard and plus sizes to address flexion instability and soft tissue balancing while minimizing implant overhang.
Zimmer Biomet (NYSE: ZBH) ha ricevuto l'approvazione 510(k) della FDA per il suo Persona® Revision SoluTion™ Femur, un impianto per la revisione del ginocchio rivoluzionario progettato per pazienti con sensibilità ai metalli. L'impianto fa parte del sistema completo Persona Revision Knee System e presenta un trattamento di indurimento superficiale proprietario per migliorare le prestazioni di usura.
Questa innovazione risponde a un bisogno medico significativo, poiché l'ipersensibilità ai metalli colpisce il 10-15% della popolazione generale e fino al 25% dei pazienti con impianti metallici. L'impianto è realizzato esclusivamente in lega di Tivanium® con il processo di indurimento superficiale Ti-Nidium, offrendo un'alternativa priva di allergeni metallici comuni come Nichel, Cobalto e Cromo.
Il prodotto sarà disponibile commercialmente negli Stati Uniti nel Q3 2025, offrendo taglie standard e plus per affrontare l'instabilità di flessione e il bilanciamento dei tessuti molli, riducendo al contempo l'eccesso dell'impianto.
Zimmer Biomet (NYSE: ZBH) ha recibido la aprobación 510(k) de la FDA para su Persona® Revision SoluTion™ Femur, un implante de rodilla de revisión revolucionario diseñado para pacientes con sensibilidades a metales. El implante forma parte del sistema integral Persona Revision Knee System y presenta un tratamiento de endurecimiento superficial patentado para mejorar el rendimiento del desgaste.
La innovación aborda una necesidad médica significativa, ya que la hipersensibilidad a metales afecta al 10-15% de la población general y hasta el 25% de los pacientes con implantes metálicos. El implante está hecho exclusivamente de aleación de Tivanium® con el proceso de endurecimiento superficial Ti-Nidium, ofreciendo una alternativa libre de alérgenos metálicos comunes como Níquel, Cobalto y Cromo.
El producto estará disponible comercialmente en EE. UU. en Q3 2025, ofreciendo tamaños estándar y plus para abordar la inestabilidad de flexión y el equilibrio de tejidos blandos, minimizando al mismo tiempo la sobresalencia del implante.
짐머 바이오메트 (NYSE: ZBH)는 금속에 민감한 환자를 위해 설계된 혁신적인 무릎 재수술 임플란트인 페르소나® 리비전 솔루션™ 대퇴골에 대해 FDA 510(k) 승인을 받았습니다. 이 임플란트는 포괄적인 페르소나 리비전 무릎 시스템의 일부로, 마모 성능을 향상시키기 위한 독점적인 표면 경화 처리를 특징으로 합니다.
이 혁신은 금속 과민증이 일반 인구의 10-15%와 금속 임플란트를 가진 환자의 최대 25%에 영향을 미친다는 중요한 의료 필요를 해결합니다. 이 임플란트는 니켈, 코발트 및 크롬과 같은 일반 금속 알레르겐이 없는 대안으로 Tivanium® 합금으로만 제작되었습니다.
이 제품은 2025년 3분기에 미국에서 상업적으로 제공될 예정이며, 플렉션 불안정성과 연조직 균형을 해결하기 위해 표준 및 플러스 사이즈를 제공하면서 임플란트의 오버행을 최소화합니다.
Zimmer Biomet (NYSE: ZBH) a obtenu l'approbation 510(k) de la FDA pour son Persona® Revision SoluTion™ Femur, un implant révolutionnaire de révision du genou conçu pour les patients sensibles aux métaux. L'implant fait partie du système complet Persona Revision Knee System et présente un traitement de durcissement de surface propriétaire pour améliorer les performances d'usure.
Cette innovation répond à un besoin médical significatif, car l'hypersensibilité aux métaux touche 10-15 % de la population générale et jusqu'à 25 % des patients ayant des implants métalliques. L'implant est fabriqué exclusivement en alliage de Tivanium® avec le processus de durcissement de surface Ti-Nidium, offrant une alternative sans allergènes métalliques courants tels que le nickel, le cobalt et le chrome.
Le produit sera commercialisé aux États-Unis au Q3 2025, offrant des tailles standard et plus pour répondre à l'instabilité de flexion et à l'équilibre des tissus mous tout en minimisant le surplomb de l'implant.
Zimmer Biomet (NYSE: ZBH) hat die FDA 510(k) Zulassung für sein Persona® Revision SoluTion™ Femur erhalten, ein revolutionäres Revisionsknieimplantat, das für Patienten mit Metallempfindlichkeiten entwickelt wurde. Das Implantat ist Teil des umfassenden Persona Revision Knee Systems und verfügt über eine proprietäre Oberflächenhärtungsbehandlung zur Verbesserung der Abriebleistung.
Die Innovation adressiert einen bedeutenden medizinischen Bedarf, da Metallüberempfindlichkeit 10-15% der allgemeinen Bevölkerung und bis zu 25% der Patienten mit metallischen Implantaten betrifft. Das Implantat besteht ausschließlich aus Tivanium®-Legierung mit dem Ti-Nidium-Oberflächenhärtungsprozess und bietet eine Alternative, die frei von häufigen Metallallergenen wie Nickel, Kobalt und Chrom ist.
Das Produkt wird voraussichtlich im Q3 2025 kommerziell in den USA erhältlich sein und bietet Standard- und Plusgrößen, um die Flexionsinstabilität und das Gleichgewicht des Weichgewebes anzugehen, während es gleichzeitig den Überhang des Implantats minimiert.
- FDA 510(k) clearance received for new revision knee implant
- Addresses large market need: 25% of implant patients affected by metal sensitivity
- 17+ years of clinical experience with Tivanium® alloy
- Enhanced wear performance through proprietary surface-hardening technology
- Commercial availability delayed until Q3 2025
Insights
Zimmer Biomet's FDA clearance for the Persona® Revision SoluTion™ Femur represents a strategic expansion of their revision knee portfolio with a specialized offering that addresses a significant unmet need. With metal hypersensitivity affecting
The revision knee market is particularly valuable as it typically commands premium pricing compared to primary knee replacements due to increased procedural complexity and specialized components. This product differentiates ZBH by offering a complete revision knee system without the most common metal allergens, potentially positioning the company to capture market share from competitors without comparable metal-sensitive options.
While commercial availability isn't expected until Q3 2025, this approval enhances Zimmer Biomet's competitive positioning in the high-value revision knee segment. The proprietary Ti-Nidium Surface Hardening Process provides technical differentiation that could offer both clinical and marketing advantages. By addressing complications that can lead to revision surgeries, ZBH demonstrates its commitment to solving specific clinical challenges while potentially reducing liability concerns related to metal sensitivity reactions.
The FDA clearance of Zimmer Biomet's Persona Revision SoluTion Femur addresses a critical clinical challenge in revision knee arthroplasty. Metal hypersensitivity reactions can cause significant complications including pain, inflammation, and implant loosening - problems that often necessitate additional surgeries and create poor outcomes for patients.
What makes this development particularly valuable is the integration of the Tivanium alloy with the Ti-Nidium surface hardening technology. This combines the biocompatibility advantages of titanium alloy with enhanced surface hardness properties that titanium components typically lack. The surface treatment achieves comparable hardness to traditional cobalt-chromium components while eliminating exposure to common allergens.
The system's design offering both standard and plus sizes specifically addresses flexion instability and soft tissue balancing challenges - two of the most difficult technical aspects of revision knee surgery. The 17-year clinical history of the underlying Tivanium alloy provides reassurance regarding the base material's safety profile, while the surface hardening technology delivers the critical wear resistance properties needed for longevity. This innovation gives surgeons a valuable alternative for the subset of patients with known or suspected metal sensitivities who require revision knee procedures.
A Revision Knee Implant Alternative for Patients with Metal Sensitivities
WARSAW, Ind., March 7, 2025 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced
"We are pleased to expand our proprietary surface-hardening technology into the revision knee space with FDA clearance of the Persona Revision SoluTion Femur, the first metal alternative option for those with certain metal sensitivities," said Joe Urban, President, Knees at Zimmer Biomet. "We are proud to offer a total revision knee construct with no deliberate addition of the most common metal allergens (Nickel, Cobalt, & Chromium). Metal sensitivity is one of the potential causes of revision procedures, and the Persona Revision SoluTion Femur is yet another innovation that delivers on our commitment to solve the most meaningful challenges in musculoskeletal health."
Cutaneous metal hypersensitivity affects 10-15 percent of the general population, while prevalence in patients with metallic implants may be as high as 25 percent.3 Patients may experience an immunological reaction against metallic particles (ions) that are released as a result of implant wear or corrosion.4 When exposed to certain metals commonly used in metal knee implants such as nickel, cobalt and chromium, people with these hypersensitivities can experience an inflammatory response, pain and implant loosening that can require a total knee replacement revision procedure.5
The Persona Revision SoluTion Femur is made solely of a proprietary Tivanium® (Ti-6Al-4V) alloy with more than 17 years of clinical use.6 The alloy is treated with the Ti-Nidium Surface Hardening Process, which results in a strengthened material that demonstrates hardness, comparable to that of metal implants, with enhanced wear performance that provides resistance to particle release.2,7 The new revision femur is offered in standard and plus sizes to address flexion instability and soft tissue balancing while minimizing implant overhang.8,9
Persona Revision SoluTion Femur will be commercially available in the
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.x.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:
- Improved Abrasion Resistance of Nitrogen-Hardened Titanium Alloy Surfaces. Current Topics in Orthopaedic Technology. Zimmer. Vol. 3, No. 6 (1991).
- Zimmer ZRR_WA_2537_12
- Akila S.,et al. Metal hypersensitivity in total hip and knee arthroplasty: Current concepts. Journal of Clinical Orthopaedics and Trauma. 2018 Jan-Mar;9(1):3-6, 2018.
- Podzimek S. Metal hypersensitivity and pro-inflammatory cytokine production in patients with failed orthopedic implants: A case-control study, Clinical Immunology, Volume 245, 2022. https://doi.org/10.1016/j.clim.2022.109152.
- Hozack, W. et al. Primary Cementless Hip Arthroplasty with a Titanium Plasma Sprayed Prosthesis. Clinical Orthopaedics and Related Research. 333: 217-25, 1996.
- Rossi SMP, et al. 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.
- Improved Abrasion Resistance of Nitrogen-Hardened Titanium Alloy Surfaces. Current Topics in Orthopaedic Technology. Zimmer. Vol. 3, No. 6 (1991).
- Royal Perth Hospital Dept. of Medical Engineering and Physics. (2005). Implant Technology and Biomaterials Bulletin: No. 4.
Australia . Department of Medical Engineering and Physics. - Shetty, RH. Surface Hardening of Orthopedic Implants. Biomaterials Engineering and Devices. Vol. 2: 191-202 (2000).
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FAQ
When will Zimmer Biomet's Persona Revision SoluTion Femur be available in the US market?
What percentage of patients with metallic implants may experience metal hypersensitivity according to ZBH's data?
What materials are used in ZBH's new Persona Revision SoluTion Femur implant?
What key metal allergens does ZBH's new Persona Revision SoluTion Femur eliminate?
