SuperBall-RC™

The SuperBall-RC™ System is an all-inside, all-suture repair device designed as a suture retention mechanism for soft tissue repair. It consists of two non-absorbable suture bundles (USP 1 UHMWPE) preloaded in a needle delivery system with a braided securing element. The device is indicated for use in rotator cuff repair procedures and percutaneous/endoscopic soft tissue procedures.

Both the SuperBall-RC and predicate FiberStitch device are all-suture designs with identical use environment, target user, and patient population. The devices share similar principles of operation involving suture approximation and securing mechanisms, though the SuperBall-RC has minor design differences and is available in two curved needle angles (12 and 18 degrees) with adjustable depth delivery.

Not stated in this summary.

Substantial equivalence is supported by bench testing demonstrating equivalent mechanical performance between the subject and predicate devices despite design differences. Shear pullout testing verified that SuperBall-RC possesses sufficient mechanical strength for both primary repair and patch anchoring configurations in rotator cuff procedures. Usability testing with physicians on cadaveric shoulder models confirmed safe and easy use with no complications, establishing that the additional rotator cuff indication does not introduce new safety concerns while maintaining the same intended purpose as the predicate.