News & Events
Arcuro Medical Announces FDA 510(k) Clearance for the SuperBall RC for Rotator Cuff Indications
27 February 2025
Arcuro Medical Ltd., (“Arcuro”) today announced that it received FDA 510(k) clearance for its new SuperBall-RC™ system for use in rotator cuff repair procedures.
Current rotator cuff re-tear rates following surgery can range from 20%-40% in patients over 50.[1] Rotator cuff augmentation with biologic or biosynthetic grafts can mitigate this risk but can be technically demanding with current surgical techniques. The new SuperBall-RC product, based on Arcuro’s SuperBall technology platform successfully used in over 5,000 meniscus repairs, addresses this unmet need.
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.
[1] Routledge et al. Re-Tear Rates Following Rotator Cuff Repair Surgery. Cureus. 2023 Jan 31;15(1)
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.
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.
Jamal Rushdy, Arcuro’s CEO
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