# K093524: Pivit a/B ST and Pivit a/B ST-R

- Pathway: 510(k) (Traditional)
- Applicant: Tyrx, Inc.
- Decided: Mar 26, 2010 after 130 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: 10 generations back to K921895 (1992). 71 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053656: Tyrx Antimicrobial Mesh, Tyrx Pharma, Inc. (2006) Summary page 1.
- K070560: LRTM Surgical Mesh, Lifecell Corp. (2007) Summary page 1.
- K090271: Hydrocoat Mesh, Promethean Surgical Devices, Inc. (2010). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K113229: Ventrio Light Hernia Patch with TRM Antimicrobial Coating (2012), 3 descendants of its own
- K133223: Xenmatrix AB Surgical Graft (2014), 2 descendants of its own
- K151177: XenMatrix AB Surgical Graft (2015), 1 descendant of its own
- K211132: ARISTE AB Mesh (2022), 0 descendants of its own
- K162193: XenMatrix AB Surgical Graft (2016), 0 descendants of its own

## Indications for use
PIVIT A/B ST 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 resorbable 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. PIVIT A/B ST is intended for single patient one-time use only.

Source page: https://510kreport.com/device/K093524
Methodology: https://510kreport.com/methodology