Not Cleared Direct

DEN230012 - Ruthless Spine RJB (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230012 · Ruthless, LLC Dba Ruthless Spine · Orthopedic device
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Jul 2023
Decision
148d
Days
Class 2
Risk

DEN230012 is an FDA 510(k) submission (not cleared) for the Ruthless Spine RJB. Classified as Intraoperative Surgical Angle Measurement Tool (product code QWL), Class II - Special Controls.

Submitted by Ruthless, LLC Dba Ruthless Spine (Irwindale, US). The FDA issued a Not Cleared (DENG) decision on July 14, 2023 after a review of 148 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4560 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Orthopedic review framework.

View all Ruthless, LLC Dba Ruthless Spine devices

Submission Details

510(k) Number DEN230012 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 16, 2023
Decision Date July 14, 2023
Days to Decision 148 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 122d · This submission: 148d
Pathway characteristics

Device Classification

Product Code QWL Intraoperative Surgical Angle Measurement Tool
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.4560
Definition An Intraoperative Surgical Angle Measurement Tool Attaches To Surgical Instruments To Measure The Angle Of The Instrument Relative To A Vertical Plumb Line In Line With Gravity. The Tool Does Not Utilize Anatomic Landmarks Or Registration To Patient Anatomy.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.