PROVIDENCE – Native Orthopaedics Inc., a sports medicine startup, recently announced it has received clearance from the U.S. Food and Drug Administration to market its Native Root System for meniscal root repair.
The system uses Dragonfly, which is a new advanced quad core knotless finger trap technology. Dragonfly gives sports medicine surgeons the instant ability to retention in knee repair procedures. The device tensions and locks when users pull the end of it, and the Dragonfly can be re-tensioned as desired.
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The Native Root System uses two single-use, sterile-packaged Dragonfly devices that are designed to reapproximate a torn meniscus root back to the original footprint.
The Dragonfly’s “trap within a trap” architecture doesn’t rely on a secondary locking feature to prevent slipping. The suture tension is sent directly to the surgeon’s fingertips, allowing for more control.
“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. “We are pleased to receive FDA-clearance for our breakthrough technology, which we believe will help significantly improve outcomes for these repairs.
Meniscus root repair is one of the fastest-growing orthopedic procedures, with an estimated 200,000 procedures underreported in the U.S., according to Native. This growth is mainly because of patient demographics and changes in activity levels of aging populations.
Out of all the total knee replacements, 78% have a medial meniscus root tear at the time of surgery – meaning there is potentially an underserved market. But with the current technology, almost 40% of meniscus root repairs fail. Just a 3-millimeter tissue creep – or elongating of the tissue that can cause a loss of tension – can lead to failure and a 5-millimeter deviation from the native attachments causes failure.
Testing of the Dragonfly system has shown a 290% increase in strength compared to others in the market and there has been less than 0.4-millimeter tissue elongation, according to Native.
“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,” said Dr. Christian Anderson, founding surgeon and chief medical officer of Native Orthopaedics.
The Native Root System will be available for commercial use in some locations beginning in May 2025.
Katie Castellani is a PBN staff writer. You may contact her at Castellani@PBN.com.
