# K053296: Mentor Aris Suprapubic Surgical Kit

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corporation
- Decided: Dec 15, 2005 after 20 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 K011251 (2001). 8 ancestors in all.
2 later devices descend 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)
- K050148: Mentor Aris Trans-Obturator Tape and Surgical Kit, Mentor Corporation (2005) Summary page 1.
- K011251: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.
- K013355: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.
- K020663: Modification to Sparc Sling System, American Medical Systems, Inc. (2002) Summary page 1.
- K021263: Modification to Sparc Sling System, American Medical Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K111233: Supris Retropubic Sling System (2011), 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 Mentor Aris Suprapubic Surgical Kit is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K053296
Methodology: https://510kreport.com/methodology