21 CFR 888.4560 — Intraoperative Surgical Angle Measurement Tool
Orthopedic (OR) · Part 888 Subpart E—Surgical Devices · § 888.4560
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QWL | Intraoperative Surgical Angle Measurement Tool | 2 | 3 | SaMD, Implant |
Special Controls
QWL — Intraoperative Surgical Angle Measurement Tool
In combination with the general controls of the FD&C Act. an intraoperative surgical angle measurement tool is subject to the following special controls:
De Novo Order DEN230012
