# K081010: Bard 3DMAX Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Davol Inc., Sub. C. R. Bard, Inc.
- Decided: Oct 7, 2008 after 181 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.
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 Mesh: named in the summary without a submission number
- (no number) Bard 3DMAX Mesh: named in the summary without a submission number
- (no number) Usher's Marlex Tubular Mesh: named in the summary without a submission number

## Most influential descendants
- K233402: Bard 3DMax Mesh (2023), 0 descendants of its own
- K092233: Surgimesh XD (2010), 0 descendants of its own

## Indications for use
The Bard 3DMAX Mesh is a sterile, single use device indicated to reinforce soft tissue where weakness exists e.g. for repair of hernias and chest wall defects.

Source page: https://510kreport.com/device/K081010
Methodology: https://510kreport.com/methodology