Zimmer Biomet Announces FDA Breakthrough Designation for Hip Replacement System

Zimmer Biomet Holdings, Inc. has announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s first-to-world iodine-treated total hip replacement system. This is the first product in Zimmer Biomet history to receive this designation.

Iodine technology integrates a controlled-release iodine surface treatment into the iTaperloc^® Complete and iG7^™ Hip System to help address challenges associated with joint replacement procedures for patients at higher risk of infection. This system recently received approval from the Japan Pharmaceutical and Medical Devices Agency (PMDA) in September, becoming the world’s first approved orthopedic implant with Iodine Technology. Indications in Japan include inhibiting bacterial adhesion on the implant surface, which is designed to address the challenging complication of Periprosthetic Joint Infections (PJI) associated with total joint arthroplasties (TJA). PJIs are estimated to occur in 1% to 2% of primary TJA procedures¹ and can have serious consequences, with mortality rates approaching the five-year mortality observed in breast cancer (11%) and far exceeding that of prostate cancer (1%).²

“The Breakthrough Device Designation from the FDA underscores the need for innovations to reduce complications that can happen with joint replacement procedures and highlights Zimmer Biomet’s commitment to advancing technologies that improve patient outcomes and enhance the overall success of musculoskeletal health interventions,” said Ivan Tornos, Chairman, President and CEO. “We look forward to working closely with the agency to bring this first-to-world innovation to patients in the United States.”

The iTaperloc^® Complete and iG7^™ Hip System combines 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 nutrient that does not cause antibiotic resistance and is commonly used in medicine as an antiseptic.

The FDA Breakthrough Devices Program offers manufacturers an opportunity to interact with experts from the agency to efficiently address topics as they arise during the regulatory review process. According to the FDA, the program provides a prioritized review of submissions and is designed to help device manufacturers receive more timely feedback from the FDA.

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.

Source: Zimmer Biomet Holdings, Inc.

The post Zimmer Biomet Announces FDA Breakthrough Designation for Hip Replacement System appeared first on Surgical Robotics Technology.