# K171634: Ortho System

- Pathway: 510(k) (Special)
- Applicant: 3Shape A/S
- Decided: Jan 17, 2018 after 229 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.
14 later devices descend from it; 6 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152086: 3Shape Ortho System, 3Shape A/S (2016) Summary page 4.

## Most influential descendants
- K191720: BRUIS Software Suite (2020), 3 descendants of its own
- K181112: Orchestrate 3D (2018), 3 descendants of its own
- K223518: iOrtho (2023), 2 descendants of its own
- K212828: BRIUS Planner Software (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 3Shape Ortho System™ is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Custom Metal Bands, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient’s dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Source page: https://510kreport.com/device/K171634
Methodology: https://510kreport.com/methodology