# K233659: Suture Wing

- Pathway: 510(k) (Special)
- Applicant: Osteonic Co., Ltd.
- Decided: Dec 26, 2023 after 41 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: 13 generations back to K911837 (1991). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202663: Suture Wing, Osteonic Co., Ltd. (2021) Summary page 5.

## Indications for use
Suture wing is intended for fixation of soft tissue to bone, using suture, in orthopedic surgery.

Source page: https://510kreport.com/device/K233659
Methodology: https://510kreport.com/methodology