Cleared Traditional

K113384 - EXTERNAL FIXATOR ST.A R 90 F4

K113384 is an FDA 510(k) clearance for EXTERNAL FIXATOR ST.A R 90 F4, manufactured by Citieffe. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K113384 · Citieffe · Orthopedic device
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May 2012
Decision
167d
Days
Class 2
Risk

K113384 is an FDA 510(k) clearance for the EXTERNAL FIXATOR ST.A R 90 F4. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Citieffe (Ormond Beach, US). The FDA issued a Cleared decision on May 1, 2012 after a review of 167 days - an extended review cycle.

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: 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 Citieffe devices

FDA 510(k) Submission Details - K113384

510(k) Number K113384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2011
Decision Date May 01, 2012
Days to Decision 167 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
45d slower than avg
Panel avg: 122d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

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 313
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K113384.
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