510(k) · Cleared
ClearedPytheas Your Guided Trajectory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pytheas Navigation Sas · OLO Orthopedic Stereotaxic Instrument
Cleared on May 11, 2026 as substantially equivalent to K252615 (Ruthless, LLC Dba Ruthless Spine, 2025) after a 243-day review. Its family tree reaches back 3 generations to 2023.
- Decided
- May 11, 2026
- Review
- 243 days
- Class
- Class II
- Product code
- OLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN230012 (2023). No later device cites it as a predicate yet.
- Root · 3 generations backDEN230012 Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine · 2023
- 2 generations backK243375 Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine · 2024
- 1 generation backK252615 Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine · 2025
- This deviceK252880 Pytheas Your Guided TrajectoryPytheas Navigation Sas · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN230012 | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | 2023 | — |
| −2 | K243375 | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | 2024 | — |
| −1 | K252615 | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | 2025 | — |
| 0 (this device) | K252880 | Pytheas Your Guided Trajectory | Pytheas Navigation Sas | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLO device
- #1 K240662 Spine Guidance Software (version 5.0); Xia 3/…score 23.7 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K252615 | Ruthless Spine RJB Cleared while this submission was under review Summary page 5…Regulatory Class: II Product Code: QWL III. Predicate Devices The subject device PYTHEAS YGT is substantially equivalent to the RUTHLESS SPINE RJB DEVICE (K252615). IV. Device Description The PYTHEAS YGT device is designed to assist the surgeon during open pedicle cannulation and screw deli… | 2025 |
| † | K123307 | Nuvasive NVM5 System | 2013 |
| † | K213768 | Bolt Navigation System | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All OLO devicesOLO Orthopedic Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OLO
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLO
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OLO
3,306in 2025
MAUDE reports naming product code OLO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 11 | 126 | 0 | 4 |
| 2010 | 9 | 113 | 1 | 4 |
| 2011 | 11 | 138 | 1 | 10 |
| 2012 | 7 | 129 | 1 | 60 |
| 2013 | 7 | 137 | 0 | 36 |
| 2014 | 10 | 119 | 3 | 245 |
| 2015 | 10 | 176 | 2 | 466 |
| 2016 | 14 | 120 | 3 | 750 |
| 2017 | 33 | 91 | 2 | 1,076 |
| 2018 | 24 | 97 | 1 | 1,230 |
| 2019 | 35 | 95 | 1 | 1,585 |
| 2020 | 34 | 89 | 6 | 2,746 |
| 2021 | 28 | 91 | 0 | 1,696 |
| 2022 | 40 | 89 | 5 | 1,568 |
| 2023 | 45 | 90 | 7 (1) | 1,493 |
| 2024 | 44 | 90 | 4 | 2,353 |
| 2025 | 40 | 119 | 1 | 3,306 |
| 2026 | 42 | 109 | 6 | — |
What is it indicated for?
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…
Read the full statement (174 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252880 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252880: Pytheas Your Guided Trajectory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252880
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026