FDA OKs Arcuro Medical’s SuperBall RC for Rotator Cuff Repair

Arcuro Medical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its SuperBall RC system for rotator cuff repairs.

Rotator cuff re-tear rates after surgery can range from 20-40% in patients over 50. Rotator cuff augmentation with biologic or biosynthetic grafts can mitigate the risk, but may be technically demanding with current surgical techniques.

SuperBall RC is based on Arcuro’s SuperBall tech platform, can address this need. The platform has been successfully used in over 5,000 meniscus repairs.

The product will enter limited user release in Q2 2025 with full launch expected in H2 2025. The company said this is ahead of schedule because of the timely FDA clearance.

Philip Davidson, MD, Arcuro’s Medical Director, commented, “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.”

Jamal Rushdy, Arcuro’s CEO, added, “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.”

The company said it will provide company updates at the upcoming Canaccord Genuity Musculoskeletal Conference and the LSI Emerging MedTech Summit 2025.