# K083839: Avaulta Solo Synthetic Support System, Avaulta Plus Biosynthetic Support System

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 15, 2009 after 23 days
- Product code: OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed)
- Device class: 3
- Regulation: 21 CFR 884.5980
- 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 K991400 (1999). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063712: Avaulta Support System/Avaulta Plus Biosynthetic Support System, C.R. Bard, Inc. (2007) Summary page 1.
- K082571: Avaulta Support System, C.R. Bard, Inc. (2008) Summary page 1.

## Indications for use
The Avaulta™ Support System is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended either as mechanical support or bridging material for the fascial defect.

Source page: https://510kreport.com/device/K083839
Methodology: https://510kreport.com/methodology