# K003323: Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205

- Pathway: 510(k) (Traditional)
- Applicant: Davol, Inc.
- Decided: Jan 22, 2001 after 90 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
44 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K050187: Parietex Composite Pco-OS and Pco-OB Meshes (2005), 31 descendants of its own
- K062915: Veritas Collagen Matrix (2006), 15 descendants of its own
- K061314: Bard Extra Large Composix Kugel  Hernia Patch (2006), 15 descendants of its own
- K110816: Parietex Optimized Composite Mesh (Pco-Osx References) (2011), 14 descendants of its own
- K081777: Ventrio Hernia Patch (2008), 14 descendants of its own

## Recalls of this device
- Jan 10, 2007 · Not classified · Z-0359-2007: PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula
- Jan 10, 2007 · Not classified · Z-0360-2007: PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula
- Dec 22, 2005 · Not classified · Z-0524-06: Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula

Source page: https://510kreport.com/device/K003323
Methodology: https://510kreport.com/methodology