# K170172: UNiD Spine Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International
- Decided: May 24, 2017 after 125 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.
7 later devices descend from it; 1 cites it directly.
0 of 31 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
- K180091: UNiD Spine Analyzer (2018), 6 descendants of its own
- K213975: KEOPS Balance Analyzer 3D (2022), 2 descendants of its own
- K212005: UNiD Spine Analyzer (2022), 2 descendants of its own
- K251629: UNiD™ Spine Analyzer (2025), 1 descendant of its own
- K223841: KBA3D (2023), 1 descendant of its own

## Indications for use
The UNiID Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons or service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgement and experience are required to properly use the software.

Source page: https://510kreport.com/device/K170172
Methodology: https://510kreport.com/methodology