# K254188: Meniscus Versaflex

- Pathway: 510(k) (Traditional)
- Applicant: GM Dos Reis Industria e Comercio Ltda.
- Decided: Feb 19, 2026 after 58 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K961555 (1996). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203393: Fast-Fix Flex, Smith & Nephew, Inc. (2021) Summary page 5.
- K252664: GMReis Suture Anchors, GM Dos Reis Industria e Comercio Ltda. (2025) Summary page 5.

## Indications for use
Meniscus Versaflex is indicated for repair of the meniscus.

Source page: https://510kreport.com/device/K254188
Methodology: https://510kreport.com/methodology