Cleared Traditional

K010303 - ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010303 · Artscan Medical Innovations · Orthopedic device
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Sep 2001
Decision
280d
Days
Class 2
Risk

K010303 is an FDA 510(k) clearance for the ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE. Classified as Tester, Stiffness, Cartilage, Arthroscopic (product code NGR), Class II - Special Controls.

Submitted by Artscan Medical Innovations (Akron, US). The FDA issued a Cleared decision on September 11, 2001 after a review of 280 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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.

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Submission Details

510(k) Number K010303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2000
Decision Date September 11, 2001
Days to Decision 280 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 122d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NGR Tester, Stiffness, Cartilage, Arthroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
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.