De Novo · Granted
GrantedRuthless Spine RJB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ruthless, LLC Dba Ruthless Spine · QWL Intraoperative Surgical Angle Measurement Tool
Granted on Jul 14, 2023 as a new device type through De Novo after a 148-day review. 3 later devices descend from it.
- Decided
- Jul 14, 2023
- Review
- 148 days
- Class
- Class II
- Product code
- QWL
- Recalls
- None
3 later devices descend from it, 1 citing it directly.
- This deviceDEN230012 Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine · 2023
- Descendant · cites it directly · 2 of its ownK243375 Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine · 2024
- Descendant · 2 generations on · 1 of its ownK252615 Ruthless Spine RJBRuthless, LLC Dba Ruthless Spine · 2025
- Descendant · 3 generations on · 0 of its ownK252880 Pytheas Your Guided TrajectoryPytheas Navigation Sas · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN230012 | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | 2023 | — |
| +1 | K243375 | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | 2024 | — |
| +2 | K252615 | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | 2025 | — |
| +3 | K252880 | Pytheas Your Guided Trajectory | Pytheas Navigation Sas | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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 QWL? 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 QWL device
- #1 K252615 Ruthless Spine RJBscore 13.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243375 | Ruthless Spine RJB | 2024 | 2 |
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?
- Of its descendants, K243375 (Ruthless, LLC Dba Ruthless Spine, 2024) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QWL devicesQWL Intraoperative Surgical Angle Measurement Tool: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QWL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QWL
Too few QWL 510(k)s in any year since 2007 to give a median.
Recalls per year · QWL
No recall names QWL since 2007.
Adverse event reports per year · QWL
No MAUDE report names QWL since 2007.
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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ruthless Spine RJB device is intended to measure the angle of surgical instruments in two planes relative to a vertical plumb line in line with gravity. It is indicated for use during lumbosacral pedicle screw implantation in conjunction with applicable spinal instrumentation and as an adjunct to fluoroscopy or intraoperative x-ray. The RJB device is not intended to replace a surgeon's judgment and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230012 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230012: Ruthless Spine RJB.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230012
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026