# K042026: Bard CK Parastomal Hernia Patch, Models 0118001, 0118002, 0118003, 0118004

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 10, 2004 after 44 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: 1 generation back to K001789 (2000). 1 ancestor in all.
75 later devices descend from it; 1 cites it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001789: Seamguard Staple Line Reinforcement Material, W. L. Gore & Associates, Inc. (2000) Summary page 2.
- (no number) Bard® Composix® Kugel® Mesh: named in the summary without a submission number

## Most influential descendants
- K043366: Permacol Surgical Implant (2004), 74 descendants of its own
- K050355: Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece, Models 5928-150, 5645-150 (2005), 54 descendants of its own
- K070560: LRTM Surgical Mesh (2007), 50 descendants of its own
- K082176: LTM-BPS Surgical Mesh (2008), 14 descendants of its own
- K080442: Seriscaffold Surgical Mesh (2008), 14 descendants of its own

## Indications for use
The Bard CK Parastomal Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of abdominal wall defects and hernias, including parastomal hernias.

Source page: https://510kreport.com/device/K042026
Methodology: https://510kreport.com/methodology