# K244015: SuperBall-RC™

- Pathway: 510(k) (Traditional)
- Applicant: Arcuro Medical, Ltd.
- Decided: Feb 19, 2025 after 55 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K925573 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221731: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire, T.A.G. Medical Products Corporation, Ltd. (2022) Summary page 5.
- K223500: SuperBall Meniscal Repair System, Arcuro Medical, Ltd. (2023) Summary page 5.

## Indications for use
The SuperBall-RC TM System is intended for use as a suture retention device to facilitate percutaneous and endoscopic soft tissue procedures. The SuperBall-RC TM System is indicated for use in rotator cuff repair procedures.

Source page: https://510kreport.com/device/K244015
Methodology: https://510kreport.com/methodology