# K252880: Pytheas Your Guided Trajectory

- Pathway: 510(k) (Traditional)
- Applicant: Pytheas Navigation Sas
- Decided: May 11, 2026 after 243 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 DEN230012 (2023). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252615: Ruthless Spine RJB, Ruthless, LLC Dba Ruthless Spine (2025). Cleared while this submission was under review Summary page 5.

## Indications for use
PYTHEAS Your Guided Trajectory is intended as an aid for use in open pedicle cannulation and screw delivery procedures in the thoracic, lumbar and sacral spine in skeletally mature patients as an augment to standard surgical technique. When used in conjunction with preoperative CT imaging and planning, the system can be used in two operating modes – Global Mode and Specific Mode: Global Mode may be used from T10 to S1 range to provide angular guidance to the surgeon for assessing the angle of approach relative to gravity. Specific Mode may be used from T1 to S1 range to provide angular guidance to the surgeon for assessing the angle of approach relative to digitized landmarks obtained on each vertebra. The system requires a user defined pedicle entry point, ascertained by visual analogy between intraoperative scene or intraoperative fluoroscopy compared to preoperative CT based imaging. The device is not intended to replace a surgeon’s judgement or standard surgical technique methods for controlling screw placement. The system is not intended to control for patient anatomical movement.

Source page: https://510kreport.com/device/K252880
Methodology: https://510kreport.com/methodology