# K092607: Ajust Adjustable Single Incision Sling

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 20, 2009 after 87 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Align® Urethral Support System: named in the summary without a submission number
- (no number) Tissue Fixation System Sling: named in the summary without a submission number
- (no number) MiniArc™ Sling System: named in the summary without a submission number
- (no number) IVS Tunneller™ System: named in the summary without a submission number
- (no number) Elevate™ Prolapse Repair System: named in the summary without a submission number

## Most influential descendants
- K121562: Altis Single Incision Cling System (2012), 2 descendants of its own
- 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
- K123179: Ajust Helical Adjustable Single-Incision Sling (2012), 0 descendants of its own

## Indications for use
The Ajust™ Adjustable Single Incision Sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K092607
Methodology: https://510kreport.com/methodology