# K243375: Ruthless Spine RJB

- Pathway: 510(k) (Special)
- Applicant: Ruthless, LLC Dba Ruthless Spine
- Decided: Nov 29, 2024 after 30 days
- Product code: QWL (Intraoperative Surgical Angle Measurement Tool)
- Device class: 2
- Regulation: 21 CFR 888.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230012 (2023). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230012: Ruthless Spine RJB, Ruthless, LLC Dba Ruthless Spine (2023) Summary page 5.

## Most influential descendants
- K252615: Ruthless Spine RJB (2025), 1 descendant of its own
- K252880: Pytheas Your Guided Trajectory (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K243375
Methodology: https://510kreport.com/methodology