# K240199: IntraOp Alignment System

- Pathway: 510(k) (Traditional)
- Applicant: Alphatec Spine, Inc.
- Decided: May 22, 2024 after 118 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K842956 (1984). 93 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170800: NuVasive LessRay with Enhanced Tracking, Nu Vasive, Incorporated (2017) Summary page 4.
- K211987: ATEC Alignment App, Alphatec Spine, Inc. (2021) Summary page 4.

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

## Indications for use
The IntraOp Alignment System is intended for use in applications where a mobile C-arm fluoroscope is incorporated to aid in diagnosis and treatment during spinal surgery. The IntraOp Alignment System is also intended to assist healthcare professionals in viewing, storing and measuring spinal alignment assessment images at various time points during surgery as well as planning spinal surgical procedures. The IntraOp Alignment System is intended for use with patients aged 18 years and older.

Source page: https://510kreport.com/device/K240199
Methodology: https://510kreport.com/methodology