A First in Orthopedics in Japan: How the Use of Iodine Is Transforming Total Hip Replacement
iTaperloc® Complete and iG7™ Hip System mark a major milestone in the fight against periprosthetic joint infection
Zimmer Biomet is entering a new chapter in infection management of joint replacement devices. Japan’s Ministry of Health, Labour and Welfare awarded Pharmaceutical and Medical Device Agency (PMDA) approval of the iTaperloc® Complete and iG7™ Hip System, making it the first orthopedic implant in the world to incorporate Iodine Technology, designed to inhibit bacterial adhesion on the implant surface. This product is not currently available in any market outside of Japan, including the United States.
Why Iodine Technology Matters
Periprosthetic Joint Infection (PJI) remains one of the most common causes of revision and a difficult complication in total joint arthroplasty (TJA), affecting approximately 1–2% of primary TJA procedures1. The mortality rate associated with PJI approaches the 5-year mortality rate observed in breast cancer (11%) and far exceeds that of prostate cancer (1%).2 By integrating iodine, an essential nutrient and widely used antiseptic, directly into the implant surface, this technology offers a non‑antibiotic approach to reducing bacterial adhesion and biofilm formation.
Behind the First Procedures: Voices from the OR and Beyond
The world’s first procedures using this technology were recently performed in Japan. To understand the significance of this milestone, we spoke with Professor Hiroyuki Tsuchiya, the technology’s developer and the surgeon who performed the inaugural cases, along with Yumi S., the first patient to receive the implant.
Q&A with Professor Hiroyuki Tsuchiya
Q: What inspired the development of Iodine Technology for orthopedic implants?
A: Initially, we considered coatings using antimicrobial metals. However, simple plating was not viable because the release of metal ions caused significant toxicity. We then developed a titanium-copper alloy, which achieved antibacterial activity while maintaining an acceptable safety profile. However, the mechanical strength decreased, which made practical application unrealistic.
That led us to iodine treatment. The now deceased, Professor Takaya of Chiba with the Institute of Technology had been working on iodine treatment for aluminum, and through collaborative research, we decided to apply this technology to titanium, which is widely used in medical devices. At that time, substantial data already existed demonstrating iodine’s antibacterial efficacy and safety, which convinced us this approach had strong potential.
Q: How does iodine’s mechanism of action differ from other antibacterial surface treatments?
A: Iodine acts through oxidative activity, simultaneously disrupting proteins, cell membranes, and nucleic acids. Because it has a multi-target bactericidal mechanism, there is no known bacterial resistance to iodine. In addition, our research and previous work has shown that the antibacterial effect of our iodine coating lasts for more than one year, but this has not been established for Zimmer Biomet’s iodine technology and ongoing research will further clarify the full duration of efficacy.
Iodine is also an essential element in the human body and is required for thyroid hormone production. Because of this, it is not recognized as foreign material and does not trigger an immune response. There is no true allergy or hypersensitivity to iodine itself. What is commonly referred to as “iodine allergy” is caused by other components in iodine-containing compounds, not iodine itself.
Furthermore, titanium rarely causes metal ion allergy. Our technology forms an oxide layer on the titanium surface, which reduces release of titanium ions. Experimentally, our iodine treatment has also demonstrated excellent osteoconductivity. Taken together, the risk of hypersensitivity or allergy is extremely low, and at present, I believe this is one of the important tools in managing PJI as it inhibits bacterial adhesion and is expected to prevent biofilm formation.
Q: How do you envision this technology influencing the future of infection management in joint replacement?
A: I believe iodine-treated implants are a breakthrough from the perspective of both safety and effectiveness and could have significant use in infection management. This technology could potentially be a true game changer in orthopedic implant surgery.
While more data is needed, I expect it will significantly contribute to reducing the risk of infection in primary total hip arthroplasty. For periprosthetic joint infection, I also believe it may increase the likelihood of successful treatment without implant removal, meaning more cases could be managed with DAIR.
It is my hope that iodine-treated total hip arthroplasty (THA) will become the standard of care.
Q: What feedback have you received from surgical teams or early patients so far?
A: At our institution, we have already performed surgery in nearly 100 cases. Feedback from the THA team has been very positive—they often comment that the implant’s color is beautiful and even captivating. The packaging design has also been very well received.
From a surgical technique perspective, surgeons report that the implant can be used just like conventional implants, without any sense of unfamiliarity. The surgical technique and instrumentation is the same as non-iodine treated implants.
Patients have also responded very positively. Knowing they are receiving an iodine treated implant gives them a sense of reassurance. Some patients who had been hesitant to proceed with surgery because of concerns around risk of infection and associated complications, have become willing to move forward specifically because iodine-coated THA is available.
Q&A with Yumi Sugiyama
Q: What led you to consider joint replacement surgery, and how did you learn about this new implant technology?
A: I was in so much pain that it often woke me up at night, and there were many things I could no longer do because of my hip pain.
I was referred internally to Yokohama Sakae Kyosai Hospital, where I had been receiving treatment for another condition.
There, I was informed about a new implant technology, and since I also have a chronic illness, I decided to undergo surgery using this technology after discussions with my physician, Toshiharu Shirai, MD, PhD.
Q: How did you feel knowing you would be among the first patients in the world to receive this implant?
A: I heard that the device approval had been obtained earlier than expected, so I assumed someone had already undergone the surgery before me. However, I was surprised to learn around the time of my surgery that it was actually the first in the world.
Q: What aspects of the technology or your care team gave you confidence going into surgery?
A: From the very first consultation, everything was explained in a clear and easy-to-understand manner. They also answered all of my concerns and questions, which gave me reassurance.
Q: What would you want other patients to know about your experience?
A: At the orthopedic clinic I previously visited, I was told that having surgery too early could lead to the need for a second operation, so it would be best to delay the surgery as much as possible. I was also advised to build muscle strength in the meantime in order to postpone the surgery.
At Yokohama Sakae Kyosai Hospital, I was told that modern implants can last up to 30 years, and that iodine-treated implants are safe for patients with pre-existing conditions. Doctors at other hospitals also told me that if I did not undergo surgery while I was still young, my condition may worsen. I was introduced to a new technology, which gave me the confidence to proceed with the surgery. Now that my pain has lessened, I am glad that I decided to undergo the procedure and I didn’t wait as long as my previous orthopedic clinic advised.
A Turning Point for Total Hip Arthroplasty
The introduction of Iodine Technology into orthopedic implants represents a meaningful step forward in addressing a persistent challenge in joint replacement surgery. With PMDA approval, subsequent U.S. Food and Drug Administration Breakthrough Device Designation, and successful first‑in‑human procedures, this innovation signals a promising future for reducing infection risk in total hip arthroplasty and elevating patient outcomes worldwide.
FDA Breakthrough Device Designation may decrease FDA review time, but does not guarantee future market authorization in the U.S. or safety of the iTaperloc® Complete with Iodine Technology and iG7™ Hip System with Iodine Technology. These devices are not cleared or approved by the U.S. FDA. They are not available for commercial sale outside of Japan.
Results are not necessarily typical, indicative, or representative of all recipient patients. Not all patients are candidates for this product and/or procedure. Results will vary due to health, weight, activity, and other variables. Zimmer Biomet does not practice medicine and the content of this site is intended for general public interest. The website and its contents do not constitute medical, legal, or any other type of professional advice. Only a medical professional can determine the treatment appropriate for your specific condition. Appropriate post-operative activities and restrictions will differ from patient to patient. Talk to your surgeon about whether joint replacement is right for you and the risks of the procedure, including the risk of implant wear, infection, loosening, breakage or failure, any of which could require additional surgery.
References:
- Izakovicova, P., Borens, O., & Trampuz, A. Perioprosthetic joint infection: current concepts and outlook. 2019; EFORT open reviews, 4(7), 482-494. https://doi.org/10.1302/2028-5241.4.180092
- Ramos MS, Benyamini B, Kompala V, et al. Perioprosthetic 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.
