# K121524: Insignia

- Pathway: 510(k) (Traditional)
- Applicant: Ormco Corp.
- Decided: Aug 9, 2012 after 78 days
- Product code: DYW (Bracket, Plastic, Orthodontic)
- 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: 1 generation back to K082207 (2009). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082207: Orthocad IQ, Cadent, Inc. (2009) Summary page 1.

## Most influential descendants
- K203442: Inbrace Orthodontic System (2021), 1 descendant of its own
- K253343: Celebrace Software (2025), 0 descendants of its own
- K123416: Insignia with Itero (2013), 0 descendants of its own

## Indications for use
The Insignia Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient.

Source page: https://510kreport.com/device/K121524
Methodology: https://510kreport.com/methodology