Arcuro Medical today announced that it received FDA 510(k) clearance for its new SuperBall-RC system for use in rotator cuff repair procedures.
"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," said Philip Davidson, MD, Arcuro's medical director.
"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," said CEO Jamal Rushdy.
The SuperBall-RC will enter a limited user release in the second quarter of 2025 in anticipation of a full launch in the second half of 2025, ahead of schedule due to the timely FDA clearance.
