# K211987: ATEC Alignment App

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: Oct 29, 2021 after 123 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: 13 generations back to K842956 (1984). 87 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141669: Surgimap, Nemaris, Inc. (2014) Summary page 4.
- K162647: NuVasive NuvaLine Mobile App, Nu Vasive, Incorporated (2017) Summary page 4.

## Most influential descendants
- K240199: IntraOp Alignment System (2024), 1 descendant of its own
- K253216: IntraOp Alignment System; CONTOUR3D Bending System (2026), 0 descendants of its own

## Indications for use
The ATEC Alignment App assists healthcare professionals in viewing, measuring, and storing images as well as planning orthopedic surgeries. The app allows the healthcare professional to perform generic and specialty measurements of the images, and to plan surgical procedures. The app includes tools for measuring anatomical components for implant selection, and offers the possibility to share data among ATEC Alignment App users. The app is for planning use only and is not intended for primary diagnostic use.

Source page: https://510kreport.com/device/K211987
Methodology: https://510kreport.com/methodology