# K151437: ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug

- Pathway: 510(k) (Traditional)
- Applicant: Atrium Medical Corporation
- Decided: Aug 27, 2015 after 90 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930669 (1993). 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)
- K930669: Atrium Polypropylene Mesh, Atrium Medical Corp. (1993) Summary page 4.
- K002093: Atrium Lite Mesh, Atrium Medical Corp. (2000) Summary page 4.

## Recalls of this device
- Nov 22, 2017 · Class II · Z-0712-2018: An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number 412298. ProLite Mesh manufactured as product code 1010306-04 was inadvertently placed inside the pouch 

## Indications for use
ProLite Mesh and ProLite Ultra Mesh are intended for use in soft tissue deficiencies including hernia repair, traumatic or surgical wounds, and chest wall reconstruction procedures requiring reinforcement with a non-absorbable supportive material. ProLoop Mesh Plug is intended for use in soft tissue deficiencies including hernia repair and traumatic or surgical wounds requiring reinforcement with a non-absorbable supportive material.

Source page: https://510kreport.com/device/K151437
Methodology: https://510kreport.com/methodology