# K162752: ARTIA Reconstructive Tissue Matrix Perforated

- Pathway: 510(k) (Traditional)
- Applicant: Lifecell Corporation
- Decided: Feb 24, 2017 after 147 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: 8 generations back to K921895 (1992). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142326: HP Tissue Matrix, Lifecell Corporation (2014) Summary page 4.

## Indications for use
ARTIA Tissue Matrix 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 which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement in plastic and reconstructive surgery. ARTIA Tissue Matrix is intended for single patient, one time use only.

Source page: https://510kreport.com/device/K162752
Methodology: https://510kreport.com/methodology