510(k) · Cleared
ClearedInbrace Orthodontic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Swift Health Systems, Inc. · PNN Orthodontic Software
Cleared on Feb 19, 2021 as substantially equivalent to K121524 (Ormco Corp., 2012) after an 88-day review. Its family tree reaches back 2 generations to 2009. 1 later device descends from it.
- Decided
- Feb 19, 2021
- Review
- 88 days
- Class
- Class II
- Product code
- PNN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K082207 (2009). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K253343Celebrace SoftwareCelebrace · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K082207 | Orthocad IQ | Cadent, Inc. | 2009 | — |
| −1 | K121524 | Insignia | Ormco Corp. | 2012 | — |
| 0 (this device) | K203442 | Inbrace Orthodontic System | Swift Health Systems, Inc. | 2021 | — |
| +1 | K253343 | Celebrace Software | Celebrace | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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 PNN? 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 PNN device
- #1 K262196 Invisalign Systemscore 14.5 · 9 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 |
|---|---|---|---|
| * | K121524 | InsigniaSummary page 4…ontic Software), EJF (Orthodontic Metal Bracket) & DZC (Orthodontic Wire) III. PRIMARY PREDICATE Insignia (Ormco Corporation), K121524 IV. DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFICATION The Inbrace Orthodontic System is a treatment planni… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253343 | Celebrace Software | 2025 | 0 |
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 12 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253343 (Celebrace, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K121524.
How does its category compare?
All PNN devicesPNN Orthodontic Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · PNN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PNN
177in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PNN
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PNN
1in 2024
MAUDE reports naming product code PNN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 5 | 229 | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 7 | 221 | 0 | 0 |
| 2021 | 4 | 58 | 1 | 0 |
| 2022 | 1 | — | 1 | 0 |
| 2023 | 3 | 90 | 0 | 0 |
| 2024 | 4 | 177 | 0 | 1 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 6 | 98 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203442: Inbrace Orthodontic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203442
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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