# K180241: Orthocaps Twinaligner

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Caps GmbH
- Decided: Sep 28, 2018 after 242 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: 5 generations back to K780619 (1978). 8 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081960: Invisalign System, Align Technology (2008) Summary page 4.
- K113618: Clearcorrect System, Clearcorrect, Inc. (2012) Summary page 4.

## Most influential descendants
- K192596: ULab Systems Dental Aligner Kit (2020), 8 descendants of its own
- K212680: LuxCreo Clear Aligner System (2022), 3 descendants of its own
- K191838: Clearform Aligners (2020), 3 descendants of its own
- K202792: BRIUS Clear Aligners (2021), 2 descendants of its own
- K232653: Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX (2024), 1 descendant of its own

## Indications for use
The Orthocaps TwinAligner® System is indicated for the alignment of teeth during orthodontic treatment of malocclusions by way of continuous gentle forces.

Source page: https://510kreport.com/device/K180241
Methodology: https://510kreport.com/methodology