OrthoPreserve has been granted both Breakthrough Device Designation and Total Product Life Cycle Advisory Program (TAP) enrollment from the U.S. Food and Drug Administration (FDA) for its Defender meniscus replacement implant.

This designation covers use of the device to treat knee pain or impairment after a meniscus surgery. Before January 2025, orthopedic device weren’t part of the TAP program. OrthoPreserve’s device is believed to be the first orthopedic device to win TAP enrollment.

The company’s implant aims to address the treatment gap that exists because of the poor outcomes of partial meniscectomy, which removes the damaged tissue. Its technology could disrupt the standard of care and displace more invasive therapies.

OrthoPreserve has demonstrated feasibility of the implant in animal, cadaver, and benchtop studies with funding from the National Institutes of Health and private investors, and the company is planning human trials in the near future.

The company plans to launch its pilot clinical trial in 2026 with potential FDA approval by 2029.

“This Breakthrough Device designation from the FDA is a major milestone for OrthoPreserve and validates the longstanding unmet medical need that our meniscus implant is designed to address,” said Jonathan Schwartz, inventor, co-founder and CEO of OrthoPreserve. “The anatomical design of the implant restores the normal stabilization and cushioning functions of the meniscus to relieve symptoms and preserve knee joint health.”