Cleared Traditional

K974406 - ORTHOPLAN (FDA 510(k) Clearance)

Class I Orthopedic device.

K974406 · Ortho-Graphics, Inc. · Orthopedic device
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Feb 1998
Decision
89d
Days
Class 1
Risk

K974406 is an FDA 510(k) clearance for the ORTHOPLAN. Classified as Template (product code HWT), Class I - General Controls.

Submitted by Ortho-Graphics, Inc. (Saltlake, US). The FDA issued a Cleared decision on February 18, 1998 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4800 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ortho-Graphics, Inc. devices

Submission Details

510(k) Number K974406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1997
Decision Date February 18, 1998
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HWT Template
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.