# K233661: Transorb™ Self-Gripping Resorbable Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Sofradim Production
- Decided: Feb 13, 2024 after 90 days
- Product code: OWT (Mesh, Surgical, Absorbable, Abdominal Hernia)
- 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: 7 generations back to K002699 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191749: TIGR Matrix Surgical Mesh, TIGR Surgical Mesh, Novus Scientific AB (2020) Summary page 4.

## Indications for use
Transorb™ Self-Gripping Resorbable Mesh is intended to be used for the reinforcement of abdominal wall soft tissues where weakness exists in open procedures involving ventral hernia repair.

Source page: https://510kreport.com/device/K233661
Methodology: https://510kreport.com/methodology