# K120831: Anchorsure

- Pathway: 510(k) (Traditional)
- Applicant: Neomedic International S.L.
- Decided: Oct 12, 2012 after 207 days
- Product code: PBQ (Fixation, Non-Absorbable Or Absorbable,  For Pelvic Use)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K042603 (2004). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042603: Gynecare Prolene Fastener System, ETHICON, Inc. (2004) Summary page 1.

## Most influential descendants
- K160569: NeuGuide (2016), 3 descendants of its own
- K213783: Apyx (2022), 2 descendants of its own
- K230730: Apyx (2023), 1 descendant of its own
- K260380: Mendit (2026), 0 descendants of its own
- K220420: Saffron Fixation System (2022), 0 descendants of its own

## Indications for use
Anchorsure is indicated for attaching suture to ligaments of the pelvic floor

Source page: https://510kreport.com/device/K120831
Methodology: https://510kreport.com/methodology