# K091659: Bard 3DMAX Light Mesh, Models: 0117310, 0117311, 0117312, 0117320, 0117321, 011732

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 3, 2009 after 55 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 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® 3DMAX™ Mesh: named in the summary without a submission number
- (no number) Mersilene Mesh: named in the summary without a submission number

## Most influential descendants
- K142711: ONFLEX Mesh (2015), 1 descendant of its own
- K251955: Onflex™ Mesh (2025), 0 descendants of its own
- K200818: 3DMax MID Anatomical Mesh (2020), 0 descendants of its own
- K192443: Dextile Anatomical Mesh (2019), 0 descendants of its own
- K142706: Modified ONFLEX Mesh (2015), 0 descendants of its own

## Indications for use
The Bard® 3DMAx TM Light Mesh will be indicated for use in the reinforcement of soft tissue where weakness exists, such as the repair of hernia defects.

Source page: https://510kreport.com/device/K091659
Methodology: https://510kreport.com/methodology