ARTICLE SUMMARY:
Active Implants’ NUsurface Meniscus Implant is on an FDA regulatory pathway that is rarely traveled by orthopedics devices. It is pursuing a de novo classification and it has one of only two-ever Breakthrough Device designations given out to date by the FDA’s Orthopedic Branch.
One of the most problematic unmet clinical needs in orthopedics is knee pain. This is especially true for patients with damaged or deteriorating menisci who are too young for a knee replacement but continue to have debilitating pain following pain management therapy, physical therapy, injections, repair techniques, or meniscectomy. Between 700,000 and 1 million arthroscopic partial meniscectomies are performed annually in the US in an attempt to alleviate knee pain and allow patients to maintain or return to an active lifestyle. For younger patients, surgeons can try to repair the tear or replace the meniscus with an allograft implant. However, for a growing number of middle-aged patients, options are limited. Recent studies show that many patients in the 40-60 age group continue to experience persistent, quality-of-life-impacting pain following meniscectomy.
Memphis, TN-based Active Implants LLC plans to be the first to offer a much-needed device solution for this under-served and rapidly increasing US patient population. The company, founded in 2004, is on an FDA regulatory path that is rare in orthopedics. This September, its NUsurface Meniscus Implant received the second-ever Breakthrough Device designation given out by the FDA’s Orthopedic Branch along with establishing a de novo review pathway. Informally referred to as a de novo 510(k), the review pathway is reserved for novel, low-to-moderate-risk devices that are not substantially equivalent to already marketed devices.
