# K041128: Suture Arrow

- Pathway: 510(k) (Traditional)
- Applicant: Linvatec Corp.
- Decided: Jul 29, 2004 after 90 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- 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
Longest line of descent: 4 generations back to K925573 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983577: Arthrex Meniscal Dart System, Arthrex, Inc. (1999) Summary page 1.
- K012334: Contour Meniscus Arrow, Models 541110, 541113, and 541116, Bionx Implants, Inc. (2001) Summary page 1.

## Indications for use
The Suture Arrow is indicated for use in repairs of knee meniscus tears that would otherwise be considered for standard repair using suture.

Source page: https://510kreport.com/device/K041128
Methodology: https://510kreport.com/methodology