# K002721: Ams Triangle Silicone-Coated Sling and Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Nov 29, 2000 after 90 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: 4 generations back to K931386 (1993). 8 ancestors in all.
113 later devices descend from it; 4 cite it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980482: Triangle Sling, Influence, Inc. (1998) Summary page 1.
- K922916: Bard Marlex Mesh Dart, C.R. Bard, Inc. (1992) Summary page 1.
- K962530: Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical Mesh, ETHICON, Inc. (1996) Summary page 1.
- K980483: Mentor Suspend Sling, Mentor Corp. (1998) Summary page 1.
- (no number) Mersilene™ Mesh: named in the summary without a submission number

## Most influential descendants
- K010931: Ams Sacral Colpopexy Sling, Model 72403501 (2001), 80 descendants of its own
- K033636: Ams Large Pore Polypropylene Mesh (2003), 79 descendants of its own
- K040521: Modification to Ams Large Pore Polypropylene Mesh (2004), 74 descendants of its own
- K040623: Ams Perigee System (2004), 70 descendants of its own
- K040537: Ams Apogee Vault Suspension System (2004), 70 descendants of its own

## Indications for use
The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh 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 the following procedures pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic fleer and sacral-colposuspension.

Source page: https://510kreport.com/device/K002721
Methodology: https://510kreport.com/methodology