# K160407: spineEOS

- Pathway: 510(k) (Traditional)
- Applicant: Onefit Medical
- Decided: Apr 8, 2016 after 52 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: 10 generations back to K896095 (1990). 23 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 30 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.

## Most influential descendants
- K232086: spineEOS (2023), 5 descendants of its own
- K240582: VEA Align; spineEOS (2024), 4 descendants of its own
- K252103: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2025), 1 descendant of its own
- K251747: VEA Align; spineEOS (2025), 1 descendant of its own
- K260322: Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (2026), 0 descendants of its own

## Indications for use
Using 3D data and models obtained with sterEOS workstation, spineEOS software is indicated for assisting healthcare professionals in viewing, measuring images as well as in preoperative planning of spine surgeries. The device includes tools for measuring spine anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software online.

Source page: https://510kreport.com/device/K160407
Methodology: https://510kreport.com/methodology