# K203442: Inbrace Orthodontic System

- Pathway: 510(k) (Traditional)
- Applicant: Swift Health Systems, Inc.
- Decided: Feb 19, 2021 after 88 days
- Product code: PNN (Orthodontic Software)
- 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: 2 generations back to K082207 (2009). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121524: Insignia, Ormco Corp. (2012) Summary page 4.

## Most influential descendants
- K253343: Celebrace Software (2025), 0 descendants of its own

## Indications for use
The Inbrace 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/K203442
Methodology: https://510kreport.com/methodology