Orthopedic

QWL · Intraoperative Surgical Angle Measurement Tool

Orthopedic · 21 CFR 888.4560 · Class 2

Overview

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:

Cleared Devices (3)

Top Applicants

• Ruthless, LLC Dba Ruthless Spine — 3 clearances