Cleared Traditional

K031181 - EXTERNAL FIXATION SYSTEMS

K031181 is the FDA 510(k) clearance for EXTERNAL FIXATION SYSTEMS by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K031181 · Smith & Nephew, Inc. · Orthopedic device
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Jul 2003
Decision
90d
Days
Class 2
Risk

K031181 is an FDA 510(k) clearance for the EXTERNAL FIXATION SYSTEMS. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on July 14, 2003 after a review of 90 days - within the typical 510(k) review window.

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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K031181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2003
Decision Date July 14, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
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 276
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K031181.
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
K033158 · Synthes (Usa) · Nov 2003
EBI XFIX DFS SYSTEM
K031919 · Ebi, L.P. · Sep 2003
MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES
K032058 · Alliance Medical Corp. · Jul 2003
SYNTHES SMALL COBINATION CLAMP-MR SAFE
K031724 · Synthes (Usa) · Jul 2003
EBI XFIX OPTIROM KNEE FIXATOR
K031093 · Ebi, L.P. · Jul 2003
EBI XFIX DFS SYSTEM
K031645 · Ebi, L.P. · Jun 2003