# K192953: APTOS Threads – Polypropylene Surgical Sutures

- Pathway: 510(k) (Traditional)
- Applicant: Aptos, LLC
- Decided: Aug 27, 2020 after 311 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K014153 (2002). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171039: Assut Filbloc Permanent Sutures, Assut Europe S.P.A. (2017) Summary page 4.

## Indications for use
The APTOS Threads — Polypropylene Surgical Sutures are indicated for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.

Source page: https://510kreport.com/device/K192953
Methodology: https://510kreport.com/methodology
