# K102766: Composix L/P Mesh with Echo PS Positioning System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 16, 2010 after 83 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K944418 (1994). 24 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061754: Bard Composite L/P Mesh, Davol Inc., Sub. C. R. Bard, Inc. (2006) Summary page 1.
- K092726: Mesh GPS - Large, Small, SM, SM Small, Surgical Structures, Ltd. (2010) Summary page 1.

## Most influential descendants
- K110820: Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System (2011), 5 descendants of its own
- K122436: Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS Positioning System (2012), 4 descendants of its own
- K130968: Ventralight ST Mesh with Echo PS Positioning System (2013), 3 descendants of its own
- K143743: ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH (2015), 2 descendants of its own
- K170294: VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse,  VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval (2017), 1 descendant of its own

## Recalls of this device
- Jan 3, 2014 · Class II · Z-0819-2014: Product labeling does not match product configuration.
- Jan 3, 2014 · Class II · Z-0820-2014: Product labeling does not match product configuration.

## Indications for use
Composix™ L/P Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects. The Echo PS™ Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.

Source page: https://510kreport.com/device/K102766
Methodology: https://510kreport.com/methodology