# K151386: C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic

- Pathway: 510(k) (Traditional)
- Applicant: Atrium Medical Corporation
- Decided: Oct 22, 2015 after 149 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: 2 generations back to K050311 (2006). 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)
- K050311: Atrium Medical Corporation C-Qur Mesh, Atrium Medical Corp. (2006) Summary page 10.
- K082748: Atrium Prolite S Mesh, Atrium Medical Corp. (2009) Summary page 10.
- K090909: C-Qur V -Patch Mesh, Atrium Medical Corp. (2009) Summary page 10.
- K100076: Atrium C-Qur Ovt Mesh, Atrium Medical Corp. (2010) Summary page 10.
- K110110: Atrium Centrilfx Mesh, Atrium Medical Corporation (2011) Summary page 10.
- K121070: C-Qur RPM Mesh, Atrium Medical Corp. (2012) Summary page 10.

## Indications for use
C-QUR Mesh 1s 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. C-QUR FX Mesh is 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. C-QUR V-Patch Mesh is 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. C-QUR TacShield Mesh is 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. C-QUR CentriFX Mesh is 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. C-QUR Mosaic Mesh is 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.

Source page: https://510kreport.com/device/K151386
Methodology: https://510kreport.com/methodology