# K202291: Button Loop

- Pathway: 510(k) (Traditional)
- Applicant: Yunyi (Beijing) Medical Device Co., Ltd.
- Decided: Jan 8, 2021 after 149 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: 10 generations back to K792022 (1979). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130814: Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM, Depuy Mitek, A Johnson & Johnson Company (2013) Summary page 5.

## Cited in the summary but kept off the family tree
- K113091: Syringes, With or without Needles, Jiangyin Caina Technology Co., Ltd. (2011). Our OCR of the scanned summary read K113091, FDA’s number for Syringes, With or without Needles (Jiangyin Caina Technology Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “RIGIDLOOP™ Cortical Fixation System”. Kept off the family tree. Summary page 7.

## Indications for use
The Button Loop is used for the fixation of soft tissue to bone in orthopedic procedures such as ACL repair.

Source page: https://510kreport.com/device/K202291
Methodology: https://510kreport.com/methodology