# K053656: Tyrx Antimicrobial Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Tyrx Pharma, Inc.
- Decided: Jul 14, 2006 after 196 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: 6 generations back to K931386 (1993). 16 ancestors in all.
24 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052864: Tyrx Surgical Mesh, Model SMPC-0501, Tyrx Pharma, Inc. (2005) Summary page 1.
- K042592: Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304, American Medical Systems, Inc. (2004) Summary page 1.
- K000185: Gore-Tex Dualmesh Plus Biomaterial (1 MM & 2MM), W. L. Gore & Associates, Inc. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K000343: Nac Y-Adp, The Kipp Group (2000). Our reading of the summary gave K000343, FDA’s number for Nac Y-Adp (The Kipp Group). Its FDA name has none of the distinctive words the summary uses for the device it names, “Spectrum Central Venous Catheter with or without Hydrophilic Coating”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K063091: Pivit CRM (Tyrx Antimicrobial Pacemaker Pouch), Model CMRM-0601 (2008), 17 descendants of its own
- K130943: Aigis RX R PM/ Aigis RX R Icd (2013), 14 descendants of its own
- K131007: Aigis RX N Medium; Aigis RX N Large (2013), 6 descendants of its own
- K132699: Aigis RX N (Medium), Aigis RX N (Large) (2013), 5 descendants of its own
- K093524: Pivit a/B ST and Pivit a/B ST-R (2010), 5 descendants of its own

## Indications for use
Is intended for the repair of hernias and other abdominal fascial deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. 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. Examples of applications where PivitABTM may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.

Source page: https://510kreport.com/device/K053656
Methodology: https://510kreport.com/methodology