Israeli medical device manufacturer Arcuro Medical has secured the US Food and Drug Administration (FDA) 510(k) approval for its SuperBall-RC system to enhance rotator cuff repair procedures.
The SuperBall-RC system is designed based on Arcuro’s SuperBall technology platform to improve surgical outcomes through a novel approach to rotator cuff augmentation.
SuperBall-RC is an all-inside, all-suture, knotless meniscal repair device that replaces hard polymer implants with flexible suture bundles.
It features a unique tensioning mechanism, providing surgeons with complete control of the repair, similar to the Inside-Out tensioning of the meniscus.
In addition, the system includes a repair suture mesh that lays flat, protecting the repaired meniscus and articulating cartilage.
The SuperBall-RC system features an extracapsular locking mechanism, which secures the repair without leaving knots in the joint space.
Arcuro is planning for a limited release of the device in the second quarter of 2025, with a full commercial launch expected in the second half of 2025.
Arcuro medical director Philip Davidson said: “The SuperBall-RC has been designed to facilitate safe and easy fixation of rotator cuff augmentation grafts.
“The device has exceeded my expectations and offers a very attractive alternative to fixate augmentation patches and enhance healing.”
According to the company, current rotator cuff re-tear rates post-surgery can range from 20%-40% in patients aged more than 50 years.
Rotator cuff augmentation with biologic or biosynthetic grafts can mitigate re-tear risks but may be technically challenging with existing surgical techniques.
Arcuro said the SuperBall-RC system, building on the success of Arcuro’s SuperBall technology, has been used in more than 5,000 meniscus repairs.
Arcuro is a portfolio company of The Trendlines Group, operating from Israel and the US, with locations in Minneapolis, Minnesota, and Naples, Florida.
The company is expanding its global distribution network to commercialise its SuperBall technology in international markets.
Arcuro CEO Jamal Rushdy said: “We are thrilled to have received this regulatory clearance and I congratulate our product development and regulatory teams for their excellent work on this important milestone for the company which will help surgeons facilitate improved rotator cuff repair outcomes for their patients.”
