Cleared Special

K243375 - Ruthless Spine RJB (FDA 510(k) Clearance)

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

K243375 · Ruthless, LLC Dba Ruthless Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
30d
Days
Class 2
Risk

K243375 is an FDA 510(k) clearance 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 Cleared decision on November 29, 2024 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ruthless, LLC Dba Ruthless Spine devices

Submission Details

510(k) Number K243375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2024
Decision Date November 29, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Consultant

Jalex Medical, LLC
Kyle Kovach

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.