# K121562: Altis Single Incision Cling System

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Nov 5, 2012 after 160 days
- Product code: PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling)
- 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: 8 generations back to K011251 (2001). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050148: Mentor Aris Trans-Obturator Tape and Surgical Kit, Mentor Corporation (2005) Summary page 1.
- K073703: Ams Miniarc Sling System, American Medical Systems, Inc. (2008) Summary page 1.
- K092607: Ajust Adjustable Single Incision Sling, C.R. Bard, Inc. (2009) Summary page 1.

## Most influential descendants
- K221874: Altis Single Incision Sling System (2023), 1 descendant of its own
- K242473: Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) (2024), 0 descendants of its own

## Indications for use
The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility, and/or intrinsic sphincter deficiency (ISD).

Source page: https://510kreport.com/device/K121562
Methodology: https://510kreport.com/methodology