Not Cleared Direct

DEN210013 - OsteoProbe (FDA 510(k) Clearance)

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

DEN210013 · Active Life Scientific, Inc. · Orthopedic device
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Aug 2021
Decision
142d
Days
Class 2
Risk

DEN210013 is an FDA 510(k) submission (not cleared) for the OsteoProbe. Classified as Bone Indentation Device (product code QGQ), Class II - Special Controls.

Submitted by Active Life Scientific, Inc. (Santa Barbara, US). The FDA issued a Not Cleared (DENG) decision on August 19, 2021 after a review of 142 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1600 - 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 Active Life Scientific, Inc. devices

Submission Details

510(k) Number DEN210013 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 30, 2021
Decision Date August 19, 2021
Days to Decision 142 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 122d · This submission: 142d
Pathway characteristics

Device Classification

Product Code QGQ Bone Indentation Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1600
Definition A Bone Indentation Device Is A Device That Measures Resistance To Indentation In Bone.
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.