Cleared Traditional

FIXEL EXTERNAL FIXATION DEVICE (K923032) - FDA 510(k) Clearance

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

K923032 · Amp, Inc. · Orthopedic device
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Oct 1993
Decision
468d
Days
Class 2
Risk

K923032 is an FDA 510(k) clearance for the FIXEL EXTERNAL FIXATION DEVICE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Amp, Inc. (Washington, US). The FDA issued a Cleared decision on October 4, 1993 after a review of 468 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Amp, Inc. devices

Submission Details

510(k) Number K923032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1992
Decision Date October 04, 1993
Days to Decision 468 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
346d slower than avg
Panel avg: 122d · This submission: 468d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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.

Regulatory Peers - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 179
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K923032.
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GAMMA LOCKING NAIL-CROSS LOCKING SCREWS
K932174 · Howmedica Corp. · Mar 1994
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K915599 · Howmedica Corp. · Oct 1993
ALTA CANCELLOUS BONE SCREW
K925127 · Howmedica Corp. · Mar 1993
MORREY ELBOW FIXATOR
K910993 · Howmedica Corp. · Nov 1992