# K173738: Archworx

- Pathway: 510(k) (Traditional)
- Applicant: Utah Medical Products and Services
- Decided: Feb 26, 2021 after 1,178 days
- Product code: NXC (Aligner, Sequential)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K780619 (1978). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192846: Argen Clear Aligner, Argen Clear Aligner Premium, Argen Corporation (2020). Cleared while this submission was under review Summary page 6.

## Indications for use
Archworx is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Archworx is intended to position teeth by way of continuous gentle force.

Source page: https://510kreport.com/device/K173738
Methodology: https://510kreport.com/methodology