# K212005: UNiD Spine Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Medicrea International, Inc.
- Decided: Jan 12, 2022 after 198 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K896095 (1990). 25 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180091: UNiD Spine Analyzer, Medicrea International (2018) Summary page 5.

## Most influential descendants
- K251629: UNiD™ Spine Analyzer (2025), 1 descendant of its own
- K261289: UNiD™ Spine Analyzer (SW3002) (2026), 0 descendants of its own

## Recalls of this device
- Dec 3, 2024 · Class II · Z-1118-2025: Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted pa

## Indications for use
The UNiD™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and 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 judgment and experience are required to properly use the software.

Source page: https://510kreport.com/device/K212005
Methodology: https://510kreport.com/methodology