Zimmer Biomet was granted FDA 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. Iodine is a biocompatible, essential nutrient that does not cause antibiotic resistance and is commonly used in medicine as an antiseptic.
This system recently received approval from the Japan Pharmaceutical and Medical Devices Agency 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 associated with total joint arthroplasties.
“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.”
Zimmer Biomet was granted FDA 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...
Zimmer Biomet was granted FDA 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. Iodine is a biocompatible, essential nutrient that does not cause antibiotic resistance and is commonly used in medicine as an antiseptic.
This system recently received approval from the Japan Pharmaceutical and Medical Devices Agency 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 associated with total joint arthroplasties.
“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.”
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