# K140967: Freedom Inguinal Hernia Repair Implant-25MM/40MM/40MM with Extended Disk

- Pathway: 510(k) (Special)
- Applicant: Insightra Medical
- Decided: Jun 10, 2014 after 57 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: 2 generations back to K922916 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113552: Freedom Inguinal Hernia Implant, Insightra Medical (2012) Summary page 1.
- K984220: Modification of Prolene (Polypropylene) Hernia System, Nonabsorbable Synthetic Surgical Mesh, ETHICON, Inc. (1999) Summary page 1.
- K922916: Bard Marlex Mesh Dart, C.R. Bard, Inc. (1992) Summary page 1.

## Indications for use
The Freedom Inguinal Hernia Implant is intended to be implanted to reinforce soft tissues where weakness for open repair of inguinal hernias exist.

Source page: https://510kreport.com/device/K140967
Methodology: https://510kreport.com/methodology