# K123356: Fortiva Porcine Dermis

- Pathway: 510(k) (Traditional)
- Applicant: Rti Biologics, Inc.
- Decided: Mar 5, 2013 after 125 days
- Product code: FTM (Mesh, Surgical)
- 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: 6 generations back to K921895 (1992). 23 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070560: LRTM Surgical Mesh, Lifecell Corp. (2007) Summary page 1.

## Most influential descendants
- K142070: Fortiva Porcine Dermis, Tutoplast Porcine Dermis (2014), 0 descendants of its own

## Indications for use
The device is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The device is intended for single patient use only.

Source page: https://510kreport.com/device/K123356
Methodology: https://510kreport.com/methodology