Orthonika, a MedTech spin-out from Imperial College London, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) 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 commercialisation of transformative medical technologies.
The designation provides prioritised regulatory engagement, helping to streamline the pathway toward clinical adoption and reduce development risk at a critical stage. Participation in the TAP program also supports alignment with clinicians, payers, and strategic partners throughout the product lifecycle.
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.”
Meniscal injuries are among the most common orthopaedic procedures worldwide, with approximately two million meniscectomies performed annually across the US and Europe. In more than 80% of irreparable cases, the standard of care remains partial or total removal of the meniscus, a procedure that can lead to persistent pain, reduced mobility, and progressive osteoarthritis.
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. Combined with regulatory recognition and proprietary technology, the company is positioned to address a multi-billion dollar market in the US and Europe.
