# K120844: Medlinx Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Medlinx Acala Pte, Ltd.
- Decided: Dec 13, 2012 after 268 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922916 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033337: Ultrapro Mesh, ETHICON, Inc. (2004) Summary page 1.
- K922916: Bard Marlex Mesh Dart, C.R. Bard, Inc. (1992) Summary page 1.

## Indications for use
The Medlinx Surgical Mesh is intended to be implanted to reinforce soft tissue where weakness exists for the repair of hernias or other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Source page: https://510kreport.com/device/K120844
Methodology: https://510kreport.com/methodology