# P100049: Linx Reflux Management System

- Pathway: PMA
- Applicant: Torax Medical
- Decided: Mar 22, 2012 after 448 days
- Product code: LEI (Implant, Anti-Gastroesophageal Reflux)
- Device class: 3
- Recalls of this device: 5 (0 Class I)
- 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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Apr 20, 2018 · Class II · Z-2041-2018: Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
- Apr 20, 2018 · Class II · Z-2040-2018: Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
- Apr 20, 2018 · Class II · Z-2038-2018: Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
- Apr 20, 2018 · Class II · Z-2039-2018: Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.
- Apr 20, 2018 · Class II · Z-2037-2018: Possible out of specification condition which may allow a bead component to separate from an adjacent wire link. This condition may result in a discontinuous or open LINX device.

Source page: https://510kreport.com/device/P100049
Methodology: https://510kreport.com/methodology