# K190767: AnatomicAligner

- Pathway: 510(k) (Traditional)
- Applicant: The Methodist Hospital Research Institute D/B/A Houston
- Decided: Mar 16, 2020 after 357 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K924630 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111641: Surgicase Orthognathic Software Wizard, Materialise NV (2011) Summary page 5.

## Indications for use
AnatomicAligner is software for pre-operative simulation of orthognathic surgical treatment options, based on imaging information from a medical scanner such as CT or MRI, in patients who have reached skeletal and dental maturity.

Source page: https://510kreport.com/device/K190767
Methodology: https://510kreport.com/methodology