Cleared Special

K221195 - OsteoProbe (FDA 510(k) Clearance)

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

K221195 · Active Life Scientific, Inc. · Orthopedic device
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Jun 2022
Decision
64d
Days
Class 2
Risk

K221195 is an FDA 510(k) clearance 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 Cleared decision on June 28, 2022 after a review of 64 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K221195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2022
Decision Date June 28, 2022
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

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.