Arcuro Medical Secures FDA 510(k) Clearance for SuperBall-RC™ Rotator Cuff Repair System

Arcuro Medical Ltd. has received FDA 510(k) clearance for its SuperBall-RC™ system, a next-generation solution designed to improve rotator cuff repair outcomes. Built on Arcuro’s proven SuperBall technology platform, successfully used in over 5,000 meniscus repairs, the new system simplifies the fixation of augmentation grafts, addressing a key challenge in rotator cuff surgery.

Rotator cuff re-tear rates can range from 20% to 40% in patients over 50, making augmentation with biologic or biosynthetic grafts a critical step in improving healing. However, existing techniques are technically demanding. SuperBall-RC™ provides a streamlined approach to graft fixation, offering surgeons an easier, more effective solution.

"The SuperBall-RC has been designed to facilitate safe and easy fixation of rotator cuff augmentation grafts," said Philip Davidson, MD, Arcuro’s Medical Director. "The device has exceeded my expectations and provides a highly effective alternative to enhance healing."

Arcuro CEO Jamal Rushdy added, "We are thrilled to receive FDA clearance for SuperBall-RC ahead of schedule. This milestone reflects the dedication of our product development and regulatory teams, and we look forward to helping surgeons achieve better outcomes for their patients."

Arcuro plans a limited user release in Q2 2025, with a full market launch in the second half of 2025.

The company will share updates at the Canaccord Genuity Musculoskeletal Conference on March 10 in San Diego, CA, and the LSI Emerging MedTech Summit 2025 on March 18 in Dana Point, CA