# K990355: Stainless Steel Soft Suture Wire

- Pathway: 510(k) (Traditional)
- Applicant: Bregma International Trading Company, Ltd.
- Decided: Jul 8, 1999 after 153 days
- Product code: LRN (Wire, Surgical)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Stainless Steel Soft Suture Wire is intended for general orthopedic surgery such as sternum closure, fracture fixation of long boneg, and patella fracture fixation. The device is also intended for: soft tissue approximation such as abdomina! wound closure and hernia repair.

Source page: https://510kreport.com/device/K990355
Methodology: https://510kreport.com/methodology