# K150553: Filbloc

- Pathway: 510(k) (Traditional)
- Applicant: Assut Europe
- Decided: May 19, 2016 after 442 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- 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 K141776 (2014). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141776: Stratafix Symmetric PDS Plus Knotless Tissue Control Devices, ETHICON, Inc. (2014) Summary page 4.

## Cited in the summary but kept off the family tree
- K018331: PDS II. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K242835: Suture-TOOL System (2025), 1 descendant of its own
- K250977: Suture-TOOL System (2025), 0 descendants of its own

## Indications for use
Filblo sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.

Source page: https://510kreport.com/device/K150553
Methodology: https://510kreport.com/methodology