# K092032: Bard Perfix Light Plug, Models 0117050, 0117060, 0117070, 0117080, 0117150, 0117160

- Pathway: 510(k) (Traditional)
- Applicant: Davol Inc., Sub. C. R. Bard, Inc.
- Decided: Dec 8, 2009 after 155 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard® Soft Mesh: named in the summary without a submission number
- (no number) Bard® Mesh Dart: named in the summary without a submission number
- (no number) Bard® PERFIX™ Plug: named in the summary without a submission number
- (no number) Mersilene Mesh: named in the summary without a submission number

## Most influential descendants
- K153236: Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay (2016), 0 descendants of its own
- K120728: Phasix Plug and Patch (2012), 0 descendants of its own

## Recalls of this device
- Oct 8, 2014 · Class II · Z-0191-2015: The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug.

## Indications for use
The Bard® PERFIX™ Light Plug is indicated for reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.

Source page: https://510kreport.com/device/K092032
Methodology: https://510kreport.com/methodology