# K083499: Exair Anterior and Posterior Prolapse Repair Systems

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: May 8, 2009 after 164 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: 10 generations back to K931386 (1993). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053414: Mentor Novasilk Mesh, Mentor Corp. (2005) Summary page 1.
- K071512: Gynecare Prolift +M* Pelvic Floor Repair Systems, ETHICON, Inc. (2008) Summary page 1.

## Most influential descendants
- K112386: Exair Anterior and Posterior Prolapse Repair System (2011), 0 descendants of its own

## Indications for use
The Coloplast Exair Anterior and Posterior prolapse repair systems are 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/K083499
Methodology: https://510kreport.com/methodology