Not Cleared Direct

DEN180012 - LOADPRO™ Intraoperative Rod Strain Sensor (FDA 510(k) Clearance)

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

DEN180012 · Intellirod Spine, Inc. · Orthopedic device
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Mar 2019
Decision
379d
Days
Class 2
Risk

DEN180012 is an FDA 510(k) submission (not cleared) for the LOADPRO™ Intraoperative Rod Strain Sensor. Classified as Intraoperative Orthopedic Strain Sensor (product code QFP), Class II - Special Controls.

Submitted by Intellirod Spine, Inc. (Akron, US). The FDA issued a Not Cleared (DENG) decision on March 28, 2019 after a review of 379 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3090 - 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: Regulatory edge-case submission. High predicate equivalence gap. With 379 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Intellirod Spine, Inc. devices

Submission Details

510(k) Number DEN180012 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 14, 2018
Decision Date March 28, 2019
Days to Decision 379 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 122d · This submission: 379d
Pathway characteristics

Device Classification

Product Code QFP Intraoperative Orthopedic Strain Sensor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3090
Definition A Strain Sensor Device Is An Adjunct Tool Intended To Measure Strain On An Orthopedic Implant In The Intraoperative Setting Only. The Device Is Not Intended To Provide Diagnostic Information Or Influence Clinical Decision-making.
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.