# K202663: Suture Wing

- Pathway: 510(k) (Traditional)
- Applicant: Osteonic Co., Ltd.
- Decided: Jun 7, 2021 after 266 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: 12 generations back to K911837 (1991). 81 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133224: Y-Knot RC All-Suture Anchor, 2.8MM - Double Loaded and Triple Loaded W/ #2 Hifi Sutures, Conmed Corporation (2014) Summary page 4.

## Most influential descendants
- K233659: Suture Wing (2023), 0 descendants of its own

## 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/K202663
Methodology: https://510kreport.com/methodology