Zimmer Biomet Announces Japan PMDA Approval of World's First Iodine-Treated Total Hip Replacement System

Rhea-AI Summary

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.

Positive

• 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

Negative

• Limited initial market availability (Japan only)
• PJI mortality rate remains significant at 11%

Insights

Medical Device Analyst

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 1-2% of primary total joint arthroplasties but carries mortality rates approaching 11% – comparable to breast cancer and exceeding prostate cancer mortality. The iodine coating works by inhibiting bacterial adhesion and preventing biofilm formation without creating antibiotic resistance.

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

WARSAW, Ind., Sept. 25, 2025 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced the Pharmaceutical and Medical Devices Agency (PMDA) in Japan approved the iTaperloc^® Complete and iG7^™ Hip System, the world's first approved orthopedic implants with Iodine Technology that inhibits bacterial adhesion on the implant surface.

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 1-2% of primary TJA procedures¹ and can have serious consequences. In fact, the mortality rate associated with PJI approaches the 5-year mortality observed in breast cancer (11%) and far exceeds that of prostate cancer (1%).²

"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 heritage^3,4,5 of the Taperloc Complete Hip System and the simplicity, efficiency and performance of the G7 Acetabular System^6,7 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 Japan further strengthens Zimmer Biomet's comprehensive portfolio of infection management solutions, which spans prevention, detection, primary and revision products," said Ivan Tornos, Chairman, President & CEO, Zimmer Biomet. "By equipping surgeons with advanced tools to identify and address infection risks throughout the continuum of care, we're helping drive safer surgical outcomes. This milestone is the latest in our robust new product cycle and underscores our unwavering commitment to delivering first-to-world, transformative innovations that address the most meaningful challenges in musculoskeletal health."

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 kirsten.fallon@zimmerbiomet.com

Investors David DeMartino 646-531-6115 david.demartino@zimmerbiomet.com   Zach Weiner 908-591-6955 zach.weiner@zimmerbiomet.com

 

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

What is the significance of Zimmer Biomet's new iTaperloc and iG7 Hip System approval in Japan?

It's the world's first approved orthopedic implants with Iodine Technology that inhibits bacterial adhesion on implant surfaces, representing a major advancement in preventing post-surgery infections.

How does the iodine technology in ZBH's new hip replacement system work?

The system uses a controlled-release iodine layer applied through advanced anodization and electrophoresis, which inhibits bacterial adhesion and biofilm formation during the postoperative period.

What is the infection rate for total joint arthroplasty that Zimmer Biomet's new system addresses?

Periprosthetic Joint Infection (PJI) occurs in 1-2% of primary total joint arthroplasty procedures, with a mortality rate approaching 11%, similar to breast cancer.

Who developed the iodine technology for Zimmer Biomet's new hip replacement system?

The technology was developed by Professor Hiroyuki Tsuchiya, Director at Yokohama Sakae Kyosai Hospital and Emeritus Professor of Orthopedic Surgery at Kanazawa University.

What are the advantages of using iodine in Zimmer Biomet's new hip implant system?

Iodine is a biocompatible, essential body nutrient that doesn't cause antibiotic resistance and is commonly used as an antiseptic in medicine.