# K050148: Mentor Aris Trans-Obturator Tape and Surgical Kit

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Corporation
- Decided: Mar 9, 2005 after 44 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: 4 generations back to K011251 (2001). 5 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031767: Mentor Obtape Trans-Obturator Tape, Mentor Corp. (2003) Summary page 2.
- K042851: Mentor Obtape Trans-Obturator Surgical Kit, Mentor Corp. (2004) Summary page 2.

## Most influential descendants
- K121562: Altis Single Incision Cling System (2012), 2 descendants of its own
- K053296: Mentor Aris Suprapubic Surgical Kit (2005), 2 descendants of its own
- K221874: Altis Single Incision Sling System (2023), 1 descendant of its own
- K111233: Supris Retropubic Sling System (2011), 1 descendant of its own
- K051533: I-STOP (2005), 1 descendant of its own

## Indications for use
The Mentor Aris Trans-obturator Surgical Kit consists of the Mentor Aris Trans-obturator Tape, an implantable, suburethral, support tape, plus introducers. The Tape and the Surgical Kit are indicated for the surgical treatment of all types of stress urinary incontinence (SUT), and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K050148
Methodology: https://510kreport.com/methodology