Cleared Traditional

K250216 - OsteoProbe (OP-100)

K250216 is an FDA 510(k) clearance for OsteoProbe (OP-100), manufactured by Active Life Scientific, Inc.. The device is a Class 2 Orthopedic device with product code QGQ cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K250216 · Active Life Scientific, Inc. · Orthopedic device
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Sep 2025
Decision
230d
Days
Class 2
Risk

K250216 is an FDA 510(k) clearance for the OsteoProbe (OP-100). 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 September 11, 2025 after a review of 230 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Active Life Scientific, Inc. devices

FDA 510(k) Submission Details - K250216

510(k) Number K250216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2025
Decision Date September 11, 2025
Days to Decision 230 days
Submission Type Traditional
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
108d slower than avg
Panel avg: 122d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QGQ Device Classification - Class 2, Special Controls

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.