The Menaflex was determined to be substantially equivalent through the premarket notification process and is indicated for use in surgical procedures for the reinforcement and repair of soft tissue injuries of the medial meniscus.
According to the company, the Menaflex implant is a device that is expected to guide new tissue growth using the body’s own healing process following removal of damaged meniscus tissue. It provides a resorbable scaffold for the growth of new tissue in the meniscus.
The company plans to seek expansion of the indication for use in the lateral meniscus through a new 510(k) application to be submitted to the FDA with data from its ongoing European post-market study. The company markets the Menaflex implant for both the medial and lateral indications in Europe.
Gerald Bisbee, Jr, chairman and CEO of ReGen Biologics, said: We are extremely pleased that the FDA has considered the recommendations of the Orthopaedic and Rehabilitation Devices Advisory Panel in support of our collagen scaffold 510(k) and that the FDA agreed to enable US marketing for this important product.