Orthonika was granted FDA’s Breakthrough Device Designation for its novel Total Meniscus Replacement (TMR) implant. The company has also been invited to participate in the FDA’s Total Product Life Cycle Advisory Program (TAP), designed to accelerate the development and commercialization of transformative medical technologies.
Orthonika’s implant is designed to replicate native meniscus biomechanics and restore joint function through a minimally invasive arthroscopic procedure. By addressing the treatment gap between meniscectomy and total knee replacement, the technology aims to preserve joint health, reduce pain, and potentially delay or prevent the need for knee replacement surgery.
With proof of concept achieved in a highly translational animal model, Orthonika is in the final stages of preclinical development.
Maria Kristina Bartolo, PhD, CEO and Founding Engineer of Orthonika, said, “This designation is a testament to both the unmet clinical need and the strength of our technology. With no approved synthetic solution currently available, total meniscus replacement has the potential to redefine the standard of care for patients with irreparable meniscus injuries. We look forward to utilising the FDA’s strategic guidance to streamline our development and bring a new joint-preserving solution to patients.”
Orthonika was granted FDA's Breakthrough Device Designation for its novel Total Meniscus Replacement (TMR) implant. The company has also been invited to participate in the FDA’s Total Product Life Cycle Advisory Program (TAP), designed to accelerate the development and commercialization of transformative medical technologies.
Orthonika’s...
Orthonika was granted FDA’s Breakthrough Device Designation for its novel Total Meniscus Replacement (TMR) implant. The company has also been invited to participate in the FDA’s Total Product Life Cycle Advisory Program (TAP), designed to accelerate the development and commercialization of transformative medical technologies.
Orthonika’s implant is designed to replicate native meniscus biomechanics and restore joint function through a minimally invasive arthroscopic procedure. By addressing the treatment gap between meniscectomy and total knee replacement, the technology aims to preserve joint health, reduce pain, and potentially delay or prevent the need for knee replacement surgery.
With proof of concept achieved in a highly translational animal model, Orthonika is in the final stages of preclinical development.
Maria Kristina Bartolo, PhD, CEO and Founding Engineer of Orthonika, said, “This designation is a testament to both the unmet clinical need and the strength of our technology. With no approved synthetic solution currently available, total meniscus replacement has the potential to redefine the standard of care for patients with irreparable meniscus injuries. We look forward to utilising the FDA’s strategic guidance to streamline our development and bring a new joint-preserving solution to patients.”
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