# K180191: SuperBall Meniscal Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Arcuro Medical, Ltd.
- Decided: Jun 5, 2018 after 133 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K925573 (1993). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092508: Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB Meniscal Repair System, Straight,, Smith & Nephew, Inc. (2010) Summary page 4.

## Most influential descendants
- K223500: SuperBall Meniscal Repair System (2023), 1 descendant of its own
- K244015: SuperBall-RC™ (2025), 0 descendants of its own

## Indications for use
The SuperBall Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as meniscal repair procedures.

Source page: https://510kreport.com/device/K180191
Methodology: https://510kreport.com/methodology