# K230195: Neo ADVISE software

- Pathway: 510(k) (Traditional)
- Applicant: Comerge AG
- Decided: Mar 8, 2024 after 408 days
- Product code: OLO (Orthopedic Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K050438 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122742: Nuvasive Bendini Spinal Rod Bending System, Nuvasive, Inc. (2012) Summary page 4.

## Indications for use
The Neo ADVISE™ System is indicated to calculate the relative positions and distances between implanted Neo Pedicle Screw System™ screws, as estimated by visually identifying screw guides, to estimate rod length, visualize rod positioning, and create a rod template that can be used to visually guide the manually creation a contoured rod by the surgeon, with a mechanical rod bender. The Neo ADVISE™ System can be used in posterior open or percutaneous spine surgery in the thoracic, lumbar, and/or sacral spine when using the Neo Pedicle Screw System™.

Source page: https://510kreport.com/device/K230195
Methodology: https://510kreport.com/methodology