# K221874: Altis Single Incision Sling System

- Pathway: 510(k) (Special)
- Applicant: Coloplast A/S
- Decided: Feb 15, 2023 after 232 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: 9 generations back to K011251 (2001). 14 ancestors in all.
1 later device descends 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)
- K121562: Altis Single Incision Cling System, Coloplast A/S (2012) Summary page 4.

## Most influential descendants
- 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/K221874
Methodology: https://510kreport.com/methodology