# K071249: Ultrapro* Hernia System, Models Uhsl, Uhsm, Uhsov

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Jun 5, 2007 after 32 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.
6 later devices descend from it; 1 cites it directly.
0 of 7 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) PROLENE* Hernia System: named in the summary without a submission number
- (no number) ULTRAPRO* Mesh: named in the summary without a submission number

## Most influential descendants
- K093932: Ethicon Physiomesh, Flexible Composite Mesh (2010), 5 descendants of its own
- K152609: GORE SYNECOR Biomaterial (2015), 3 descendants of its own
- K173333: GORE ENFORM Biomaterial (2018), 1 descendant of its own
- K222919: GORE® ENFORM Biomaterial (2022), 0 descendants of its own
- K163576: GORE SYNECOR Preperitoneal Biomaterial (2017), 0 descendants of its own

## Indications for use
This product is indicated for open repair of abdominal wall hernia defects.

Source page: https://510kreport.com/device/K071249
Methodology: https://510kreport.com/methodology