# K111233: Supris Retropubic Sling System

- Pathway: 510(k) (Special)
- Applicant: Coloplast A/S
- Decided: Jun 24, 2011 after 53 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: 6 generations back to K011251 (2001). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053296: Mentor Aris Suprapubic Surgical Kit, Mentor Corporation (2005) Summary page 1.

## 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 Supris Retropubic Sling System is an implantable, sub-urethral, support tape indicated for the surgical treatment of female stress urinary incontinence (SUT), resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The sling is plaiced retropubically using two disposable introducers using either a "top down" or "bottom up" surgical approach

Source page: https://510kreport.com/device/K111233
Methodology: https://510kreport.com/methodology