# K192173: ROSA ONE Spine application

- Pathway: 510(k) (Traditional)
- Applicant: Medtech S.A
- Decided: Oct 29, 2019 after 78 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: 8 generations back to K002053 (2000). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182848: ROSA ONE Spine application, Medtech S.A (2019) Summary page 4.

## Indications for use
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard surgical instruments during spine surgeries. Guidance is based on an intraoperative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is intended for the placement of pedicle screws in vertebrae with a posterior approach in the thoracolumbar region.

Source page: https://510kreport.com/device/K192173
Methodology: https://510kreport.com/methodology