Cleared Traditional

K012193 - AMC ANTIMICROBIAL PIN/WIRE SLEEVE

K012193 is the FDA 510(k) clearance for AMC ANTIMICROBIAL PIN/WIRE SLEEVE by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code JEC) cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K012193 · Smith & Nephew, Inc. · Orthopedic device
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Jul 2002
Decision
364d
Days
Class 2
Risk

K012193 is an FDA 510(k) clearance for the AMC ANTIMICROBIAL PIN/WIRE SLEEVE. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on July 11, 2002 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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. Elevated predicate reliance profile. 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 K012193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2001
Decision Date July 11, 2002
Days to Decision 364 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
242d slower than avg
Panel avg: 122d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEC Component, Traction, Invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JEC Component, Traction, Invasive

All 43
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K012193.
KLSA MARTIN HAND DISTRACTOR
K042066 · KLS-Martin L.P. · Aug 2004
HOFFMANN II COMPACT BALTIMORE COUPLING
K031941 · Howmedica Osteonics Corp. · Jul 2003
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676 · Smith & Nephew, Inc. · Sep 2002
HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST
K003848 · Howmedica Osteonics Corp. · Jan 2001
BREMER HALO SYSTEM TITANIUM SKULL PIN
K993099 · Depuyacromed · Dec 1999
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
K971755 · Howmedica Corp. · Jul 1997