# K030031: Soft Tissue Anchoring Washers

- Pathway: 510(k) (Traditional)
- Applicant: Accu-Speed, Incorporated
- Decided: Jan 28, 2003 after 25 days
- Product code: KGS (Retention Device, Suture)
- Device class: 1
- Regulation: 21 CFR 878.4930
- 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 Soft Tissue Anchoring Washers [washers], [washer, bolt nut] are to be used for anchoring soft tissue to bone.

Source page: https://510kreport.com/device/K030031
Methodology: https://510kreport.com/methodology