# K042592: Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Dec 14, 2004 after 82 days
- Product code: OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator)
- 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: 5 generations back to K931386 (1993). 9 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002721: Ams Triangle Silicone-Coated Sling and Surgical Mesh, American Medical Systems, Inc. (2000) Summary page 1.
- K980483: Mentor Suspend Sling, Mentor Corp. (1998) Summary page 1.

## Most influential descendants
- K053656: Tyrx Antimicrobial Mesh (2006), 24 descendants of its own
- 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

## Indications for use
The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to pubourethral support and bladder support.

Source page: https://510kreport.com/device/K042592
Methodology: https://510kreport.com/methodology