Cleared Traditional

K841621 - BACK RADIUS CUTTER

K841621 is an FDA 510(k) clearance for BACK RADIUS CUTTER, manufactured by Plastafil, Inc.. The device is a Class 1 Orthopedic device with product code HTX cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K841621 · Plastafil, Inc. · Orthopedic device
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Sep 1984
Decision
154d
Days
Class 1
Risk

K841621 is an FDA 510(k) clearance for the BACK RADIUS CUTTER. Classified as Rongeur (product code HTX), Class I - General Controls.

Submitted by Plastafil, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1984 after a review of 154 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 Plastafil, Inc. devices

FDA 510(k) Submission Details - K841621

510(k) Number K841621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1984
Decision Date September 20, 1984
Days to Decision 154 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

HTX Device Classification - Class 1, General Controls

Product Code HTX Rongeur
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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.