# K211132: ARISTE AB Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Ariste Medical, LLC
- Decided: Mar 18, 2022 after 336 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: 11 generations back to K921895 (1992). 72 ancestors in all.
No later device cites it as a predicate yet.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093524: Pivit a/B ST and Pivit a/B ST-R, Tyrx, Inc. (2010) Summary page 4.

## Indications for use
ARISTE AB Mesh 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. 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 non-absorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation. ARISTE AB Mesh is intended for single patient one-time use only.

Source page: https://510kreport.com/device/K211132
Methodology: https://510kreport.com/methodology