Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.4560](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4560) → QWL — Intraoperative Surgical Angle Measurement Tool

# QWL · Intraoperative Surgical Angle Measurement Tool

_Orthopedic · 21 CFR 888.4560 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/QWL

## Overview

- **Product Code:** QWL
- **Device Name:** Intraoperative Surgical Angle Measurement Tool
- **Regulation:** [21 CFR 888.4560](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4560)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)
- **Implant:** yes

## Identification

The Ruthless Spine RJB is an intraoperative surgical angle measurement tool that attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. It measures axial and sagittal angles in two planes. 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 device does not utilize anatomic landmarks or registration to patient anatomy and is not intended to replace a surgeon's clinical judgment.

## Classification Rationale

Class II (special controls). The device is subject to the general controls of the FD&C Act and the identified special controls to mitigate risks such as implant malpositioning, adverse tissue reaction, infection, software error, electrical shock, and electromagnetic interference.

## Special Controls

In combination with the general controls of the FD&C Act. an intraoperative surgical angle measurement tool is subject to the following special controls:

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K252615](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/QWL/K252615.md) | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | Sep 17, 2025 | SESE |
| [K243375](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/QWL/K243375.md) | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | Nov 29, 2024 | SESE |
| [DEN230012](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/QWL/DEN230012.md) | Ruthless Spine RJB | Ruthless, LLC Dba Ruthless Spine | Jul 14, 2023 | DENG |

## Top Applicants

- Ruthless, LLC Dba Ruthless Spine — 3 clearances

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/QWL](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/QWL)

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