Zimmer Biomet Announces Japan PMDA Approval of World's First Iodine-Treated Total Hip Replacement System
Zimmer Biomet (NYSE:ZBH) has received PMDA approval in Japan for the iTaperloc® Complete and iG7™ Hip System, marking a significant breakthrough as the world's first iodine-treated total hip replacement system. The innovative technology inhibits bacterial adhesion and prevents biofilm formation on implant surfaces.
The system addresses Periprosthetic Joint Infection (PJI), which affects 1-2% of primary total joint arthroplasty procedures and carries a mortality rate comparable to breast cancer (11%). The technology, developed by Professor Hiroyuki Tsuchiya, uses a controlled-release iodine layer through advanced anodization and electrophoresis.
This earlier-than-expected approval strengthens Zimmer Biomet's infection management solutions portfolio, combining the clinical heritage of the Taperloc Complete Hip System with the G7 Acetabular System's performance.
Zimmer Biomet (NYSE:ZBH) ha ottenuto l'approvazione PMDA in Giappone per il sistema iTaperloc® Complete e iG7™ Hip, una svolta significativa: è il primo impianto di protesi totale dell’anca trattato con iodio al mondo. La tecnologia innovativa inibisce l’adesione batterica e previene la formazione di biofilm sulle superfici dell’impianto.
Il sistema affronta l’Infezione Periprotesica dell’Articolazione (PJI), che colpisce l’1-2% degli interventi di artroplastica totale primaria e comporta una mortalità paragonabile a quella del cancro al seno (11%). La tecnologia, sviluppata dal professor Hiroyuki Tsuchiya, usa uno strato di iodio a rilascio controllato tramite anodizzazione avanzata ed elettroforesi.
Questa approvazione anticipata rafforza il portafoglio di soluzioni per la gestione delle infezioni di Zimmer Biomet, combinando l’eredità clinica del sistema Taperloc Complete Hip con le prestazioni del sistema acetabolare G7.
Zimmer Biomet (NYSE:ZBH) ha obtenido la aprobación de la PMDA en Japón para el sistema iTaperloc® Complete y iG7™ Hip, un avance significativo como el primer sistema de reemplazo total de cadera tratado con yodo en el mundo. La tecnología innovadora inhibe la adhesión bacteriana y previene la formación de biofilm en las superficies del implante.
El sistema aborda la Infección Periprotésica de la Articulación (PJI), que afecta al 1-2% de las intervenciones de artroplastia total primaria y conlleva una tasa de mortalidad comparable a la del cáncer de mama (11%). La tecnología, desarrollada por el profesor Hiroyuki Tsuchiya, utiliza una capa de yodo de liberación controlada mediante anodización avanzada y electrodeposición.
Esta aprobación anticipada fortalece la cartera de soluciones de gestión de infecciones de Zimmer Biomet, combinando la herencia clínica del sistema Taperloc Complete Hip con el rendimiento del sistema acetabular G7.
Zimmer Biomet (NYSE:ZBH)가 일본에서 iTaperloc® Complete 및 iG7™ Hip 시스템에 대한 PMDA 승인을 받아, 세계 최초로 요오드 처리된 전 인공고관절 시스템으로 큰 돌파구를 열었습니다. 이 혁신 기술은 임플란트 표면의 세균 부착을 억제하고 바이오필름 형성을 방지합니다.
이 시스템은 주위 인공관절 감염(PJI)을 다루는데, 이는 1-2%의 1차 총 관절성형 수술에 영향을 주며 유방암과 유사한 11%의 사망률을 보입니다. 이 기술은 교수가 개발한 것으로, Hiroyuki Tsuchiya 교수에 의해 고급 산화처리 및 전기침전화를 통한 제어된 방출 요오드 층을 사용합니다.
예상보다 이른 이 승인은 Zimmer Biomet의 감염 관리 솔루션 포트폴리오를 강화하며, Taperloc Complete Hip 시스템의 임상 전통과 G7 관절와 시스템의 성능을 결합합니다.
Zimmer Biomet (NYSE:ZBH) a obtenu l’approbation PMDA au Japon pour le système iTaperloc® Complete et iG7™ Hip, marquant une avancée majeure en tant que premier système prothétique total de la hanche traité à l’iode au monde. La technologie innovante inhibe l’adhésion bactérienne et prévient la formation de biofilm sur les surfaces de l’implant.
Le système traite l’Infection Periprothétique de l’Articulation (PJI), qui affecte 1-2% des arthroplasties totales primaires et présente un taux de mortalité comparable à celui du cancer du sein (11%). La technologie, développée par le professeur Hiroyuki Tsuchiya, utilise une couche d’iode à libération contrôlée grâce à une anodisation avancée et une électrodéposition.
Cette approbation anticipée renforce le portefeuille de solutions de gestion des infections de Zimmer Biomet, en associant l’héritage clinique du système Taperloc Complete Hip à la performance du système acétabulaire G7.
Zimmer Biomet (NYSE:ZBH) hat in Japan die PMDA-Zulassung für das iTaperloc® Complete und iG7™-Hüftsystem erhalten, was einen bedeutenden Durchbruch darstellt, da es sich um das weltweit erste mit Jod behandelte totale Hüftimplantatsystem handelt. Die innovative Technologie hemmt die bakteriellen Adhäsionen und verhindert die Biofilmbildung auf den Implantatoberflächen.
Das System adressiert die periprothetische Infektion (PJI), die 1-2% der primären totalen Gelenkoperationen betrifft und eine Mortailitätsrate hat, die mit Brustkrebs (11%) vergleichbar ist. Die vom Professor Hiroyuki Tsuchiya entwickelte Technologie nutzt eine kontrollierte Jodfreisetzungsschicht durch fortgeschrittene Anodisation und Elektroosporation.
Diese vorgezogene Zulassung stärkt das Portfolio an Infektionsmanagement-Lösungen von Zimmer Biomet, indem sie die klinische Tradition des Taperloc Complete Hip-Systems mit der Leistung des G7-Acetabulum-Systems verbindet.
Zimmer Biomet (NYSE:ZBH) حصلت على موافقة PMDA في اليابان لنظام iTaperloc® Complete و iG7™ Hip، مما يمثل طفرة كبيرة كأول نظام استبدال مفصل كتف كلي معالج باليود في العالم. التقنية المبتكرة تقاوم التصاق البكتيريا وتمنع تكوّن الأغشية الحيوية على أسطح الزرعات.
يوجه النظام مشكلة العدوى المحيطة بالزرعات (PJI)، التي تؤثر على 1-2% من إجراءات تعظيم المفاصل الأولية وتملك معدل وفيات يقارن بسرطان الثدي (11%). التقنية، التي طورها الأستاذ هيرويوكي توشيا، تستخدم طبقة يود ذات إطلاق محكوم عبر أكيدونية متقدمة وترسيب كهربي.
هذه الموافقة المبكّرة تقوّي محفظة حلول إدارة العدوى لدى Zimmer Biomet، مدمجة التراث السريري لنظام Taperloc Complete Hip مع أداء نظام G7 Acetabular.
Zimmer Biomet（纽交所代码：ZBH） 已在日本获得 PMDA 批准用于 iTaperloc® Complete 与 iG7™ 髋系统，这是全球首个碘处理的全髋关节置换系统，标志着一项重大突破。该创新技术可抑制细菌附着并防止植入物表面形成生物膜。
该系统针对 假关节周围感染（PJI），其发生在初次全关节置换手术中的比例为 1-2%，死亡率与乳腺癌相当（11%）。该技术由津田教授 Hiroyuki Tsuchiya 研发，通过先进的阳极化和电泳实现受控释放的碘层。
这项提前批准增强了 Zimmer Biomet 的感染管理解决方案组合，将 Taperloc Complete Hip 系统的临床传统与 G7 髋臼系统的性能结合起来。
- First-to-world innovation in orthopedic implants with iodine technology
- Earlier than expected regulatory approval in Japan
- Addresses serious medical issue affecting 1-2% of total joint procedures
- Technology uses biocompatible iodine that doesn't cause antibiotic resistance
- Limited initial market availability (Japan only)
- PJI mortality rate remains significant at 11%
Insights
Japan's approval of Zimmer Biomet's iodine-treated hip implants marks a significant innovation addressing the serious challenge of post-surgical infections.
Zimmer Biomet's newly PMDA-approved iTaperloc® Complete and iG7™ Hip System represents a noteworthy advancement in orthopedic implant technology. As the world's first iodine-treated total hip replacement system, this innovation directly tackles one of orthopedics' most persistent challenges: periprosthetic joint infections (PJI).
The technology's significance is underscored by the serious nature of PJI, which affects
What makes this approval particularly valuable is the combination of proven clinical systems (Taperloc Complete and G7 Acetabular) with the novel iodine technology. The company notes this approval came earlier than expected, suggesting an accelerated regulatory pathway that could bode well for future market expansions.
For orthopedic surgeons, these implants represent a preventative approach to infection management rather than merely reactive treatment options. This fits into Zimmer Biomet's broader infection management strategy spanning prevention, detection, and revision products – addressing the complete continuum of care.
While Japan represents only one market, this first regulatory approval establishes Zimmer Biomet's leadership position in infection prevention technology that could ultimately influence standard of care globally and strengthen their competitive advantage in the total joint replacement market.
iTaperloc® Complete and iG7™ Hip System with Iodine Technology inhibits bacterial adhesion and prevents biofilm formation on the implant surface to help address the issue of Periprosthetic Joint Infection after total joint replacement
Implant-associated bacterial infection or Periprosthetic Joint Infection (PJI) remains one of the most common causes of revision and a challenging complication of total joint arthroplasty (TJA). PJI is estimated to occur in 1
"Iodine Technology represents a significant advancement in orthopedic implant design," said Professor Hiroyuki Tsuchiya, Director at Yokohama Sakae Kyosai Hospital and Emeritus Professor of Orthopedic Surgery at Kanazawa University. Prof. Tsuchiya, who developed the technology, explained: "By integrating a controlled-release iodine layer through advanced anodization and electrophoresis, we created an implant that inhibits bacterial adhesion and biofilm formation during the postoperative period. This innovation combines simplicity and sophistication to help address the issue of PJI after total joint replacement."
iTaperloc and iG7 combine the long-standing clinical heritage3,4,5 of the Taperloc Complete Hip System and the simplicity, efficiency and performance of the G7 Acetabular System6,7 with Iodine Technology. Iodine is a biocompatible, essential body nutrient that does not cause antibiotic resistance and is commonly used in medicine as an antiseptic. Iodine Technology applies iodine to the implant's surface during the manufacturing process to inhibit biofilm formation.
"The earlier-than-expected approval of iTaperloc Complete and iG7 Hip System in
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.
Contacts:
Media Troy Kirkpatrick 614-284-1926 troy.kirkpatrick@zimmerbiomet.com
Kirsten Fallon 781-779-5561 | Investors David DeMartino 646-531-6115 david.demartino@zimmerbiomet.com
Zach Weiner 908-591-6955 |
1 Izakovicova, P., Borens, O., & Trampuz, A. (2019). Periprosthetic joint infection: current concepts and outlook. EFORT open reviews, 4(7), 482–494. https://doi.org/10.1302/2058-5241.4.180092
2 Ramos MS, Benyamini B, Kompala V, et al. Periprosthetic joint infection mortality after total hip arthroplasty is comparable to 5-year rates of common cancers: a meta-analysis. J Arthroplasty. 2025;1-7. https://doi.org/10.1016/j.arth.2025.04.036.
3 McLaughlin JR, Lee KR. Total hip arthroplasty with an uncemented tapered femoral component. J Bone Joint Surg Am. 2008 Jun;90(6):1290-6. https://doi.org/10.2106/JBJS.G.00771.
4 Teloken MA, Bissett G, Hozack WJ, Sharkey PF, Rothman RH. Ten to fifteen-year follow-up after total hip arthroplasty with a tapered cobalt-chromium femoral component (tri-lock) inserted without cement. J Bone Joint Surg Am. 2002 Dec;84(12):2140-4. https://doi.org/10.2106/00004623-200212000-00003.
5 Parvizi J, Keisu KS, Hozack WJ, Sharkey PF, Rothman RH. Primary total hip arthroplasty with an uncemented femoral component: a long-term study of the Taperloc stem. J Arthroplasty. 2004 Feb;19(2):151-6. https://doi.org/10.1016/j.arth.2003.10.003.
6 Latest ODEP ratings can be found at http://www.odep.org.uk; G7 OsseoTi™ Acetabular Shell (5A), G7 OsseoTi® Dual Mobility Construct (7A), G7 Cementless Acetabular Component (10A), G7 PPS® BoneMaster™ Dual Mobility Construct (5A*), G7 PPS®Dual Mobility Construct (7A), G7 PPS Bonemaster (10A). ODEP rating received in 2024/2025.
7 Berend KR, Adams JB, Morris MJ, Lombardi A V. Three-Year Results with a Ringless Third- Generation Porous Plasma Sprayed Acetabular Component in Primary Total Hip Arthroplasty. Surg Technol Int [Internet]. 2017 Jan; 30:295—299. Available from: http://europepmc.org/abstract/MED/28072898
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SOURCE Zimmer Biomet Holdings, Inc.
FAQ
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