510(k) · Cleared
ClearedArchworx
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Utah Medical Products and Services · NXC Aligner, Sequential
Cleared on Feb 26, 2021 as substantially equivalent to K192846 (Argen Corporation, 2020) after a 1,178-day review. Its family tree reaches back 4 generations to 1978.
- Decided
- Feb 26, 2021
- Review
- 1,178 days
- Class
- Class II
- Product code
- NXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K780619 (1978). No later device cites it as a predicate yet.
- Root · 4 generations backK780619 Preformed Tooth PositionerTp Laboratories, Inc. · 1978
- 3 generations backK981095 Align SystemAlign Technology · 1998
- 2 generations backK183229 Argen Clear AlignerArgen Corporation · 2019
- 1 generation backK192846 Argen Clear Aligner, Argen Clear Aligner PremiumArgen Corporation · 2020
- This deviceK173738 ArchworxUtah Medical Products and Services · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K780619 | Preformed Tooth Positioner | Tp Laboratories, Inc. | 1978 | — |
| −3 | K981095 | Align System | Align Technology | 1998 | — |
| −2 | K183229 | Argen Clear Aligner | Argen Corporation | 2019 | — |
| −1 | K192846 | Argen Clear Aligner, Argen Clear Aligner Premium | Argen Corporation | 2020 | — |
| 0 (this device) | K173738 | Archworx | Utah Medical Products and Services | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NXC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NXC device
- #1 K220287 Invisalign Systemscore 20.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192846 | Argen Clear Aligner, Argen Clear Aligner Premium Cleared while this submission was under review Summary page 6…and as prescribed. Primary Predicate Argen Clear Aligner and Argen Clear Aligner Premium (K192846) Reference Device 3Shape Ortho System Software (K180941) Conclusion Comparison of the Proposed Devi… | 2020 |
| † | K180941 | Ortho System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 43 years and passes through 4 companies; a new generation was cleared every 20.2 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K192846.
How does its category compare?
All NXC devicesNXC Aligner, Sequential: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NXC
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NXC
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NXC
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NXC
4,523in 2025
MAUDE reports naming product code NXC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 11 |
| 2011 | 0 | — | 0 | 59 |
| 2012 | 2 | — | 0 | 24 |
| 2013 | 4 | 124 | 0 | 28 |
| 2014 | 0 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 43 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 3 | 85 | 0 | 47 |
| 2018 | 11 | 116 | 0 | 67 |
| 2019 | 16 | 182 | 0 | 127 |
| 2020 | 16 | 230 | 0 | 175 |
| 2021 | 20 | 97 | 0 | 929 |
| 2022 | 19 | 137 | 0 | 605 |
| 2023 | 13 | 152 | 0 | 433 |
| 2024 | 14 | 105 | 2 | 8,991 |
| 2025 | 11 | 61 | 0 | 4,523 |
| 2026 | 5 | 127 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173738: Archworx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173738
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026