Providence, RI-based Native Orthopaedics has received FDA 510(k) clearance for its Native Root System powered by Dragonfly technology, a novel approach to meniscal root repair that could significantly improve outcomes for a procedure with historically high failure rates.
The Dragonfly technology features a quad core knotless finger trap design that provides surgeons with instant retensioning capabilities during knee repair procedures. This innovation allows surgeons to create precise fixation in one fluid motion by simply pulling the end of the device, which tensions and locks, with the ability to retension as needed during the procedure.
Technology Design and Advantages
The Native Root System consists of two single-use sterile-packed Dragonfly devices specifically designed to reapproximate a torn meniscal root back to its native footprint. According to the company, the platform utilizes a patented "trap within a trap" architecture that doesn't rely on secondary locking features to prevent slippage.
Biomechanical testing has demonstrated significant advantages over current standard of care options, including:
- 290% increase in ultimate strength compared to market alternatives
- Less than 0.4 mm elongation under cyclic loading
- Direct transmission of suture tension to the surgeon's fingertips for improved control
- Ability to recover the "unrecoverable" creep through retensioning
"With the introduction of the Dragonfly platform to the market, Native Orthopaedics aims to improve the standard of care for all of sports medicine, starting with the meniscal root repair use case," said Tom Gamache, CEO of Native Orthopaedics. "I am proud of our team for translating this from a concept to a clinically ready best-in-class solution in under a year."
Addressing an Unmet Clinical Need
Meniscal root repair represents one of the fastest-growing orthopedic procedures worldwide, with an estimated 200,000 procedures performed annually in the United States alone. The growth is driven by both patient demographics and increased activity levels in aging populations.
Current surgical solutions face significant limitations:
- Nearly 40% of meniscal root repairs fail with existing technologies
- 78% of total knee replacements have a medial meniscus root tear at the time of surgery, indicating a potentially underserved market
- Just 3 mm of tissue creep can lead to repair failure
- A 5 mm deviation of fixation from the native attachment can result in significantly altered biomechanics
Dr. Christian Anderson, Founding Surgeon and Chief Medical Officer of Native Orthopaedics, emphasized the clinical significance: "Meniscal root tears have been called a 'silent epidemic,' and if managed conservatively, have dire consequences, including a 95% clinical failure rate with 50% conversion to knee arthroplasty within 10 years after the injury."
Development and Commercial Timeline
The Native Root System has been developed through what the company describes as years of surgeon-driven research and design advancements. The supporting instrumentation was designed with surgeon input throughout the development process to address challenges in current root repair systems regarding precise tensioning, low-creep fixation, tunnel accuracy, and suture passing misfires.
The technology is protected by 12 issued patents, with more than 30 additional patents under review, including worldwide coverage.
Native Orthopaedics plans to make the system available for commercial use in select locations starting in May 2025. The company is currently a privately held startup actively fundraising pre-series A, with a series A round anticipated in the coming months.
Future Applications
While the initial FDA clearance focuses on meniscal root repair, Native Orthopaedics indicates that the Dragonfly platform technology is designed to enable scalability of knotless fixation across sports medicine applications.
The company also reports having one end-stage development product targeting ACL repairs and a pipeline of future products for knee, shoulder, and ankle procedures.
"Our mission is patient-centered and surgeon-focused, and I believe the Dragonfly technology will empower surgeons to restore the native anatomy in ways that have previously not been allowed," added Dr. Anderson. "Having evaluated all commercially available products for meniscal root repair, I can confidently say that the Native Root System is the simplest, most efficient, and best solution available to improve outcomes, all with no knots and no anchors."
