# DEN230012: Ruthless Spine RJB

- Pathway: De Novo (Direct)
- Applicant: Ruthless, LLC Dba Ruthless Spine
- Decided: Jul 14, 2023 after 148 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
No predicates in its family tree.
3 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K243375: Ruthless Spine RJB (2024), 2 descendants of its own
- 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/DEN230012
Methodology: https://510kreport.com/methodology