Cleared Special

K062408 - SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD

K062408 is the FDA 510(k) clearance for SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code KWL) cleared through the Special 510(k) pathway after a 26-day FDA review.

K062408 · Smith & Nephew, Inc. · Orthopedic device
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Sep 2006
Decision
26d
Days
Class 2
Risk

K062408 is an FDA 510(k) clearance for the SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on September 12, 2006 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K062408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2006
Decision Date September 12, 2006
Days to Decision 26 days
Submission Type Special
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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 75
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K062408.
CORIN OPTIMOM MODULAR HEAD
K111911 · Corin USA · Aug 2011
CORIN ADAPTOR SLEEVE
K071471 · Howmedica Osteonics Corp. · Sep 2007
CORIN UNIPOLAR MODULAR HEAD
K063791 · Corin USA · Apr 2007
SMITH & NEPHEW MODULAR FEMORAL HEAD
K061243 · Smith & Nephew, Inc. · Jul 2006
SOLITUDE UNIPOLAR HEAD
K042973 · Ortho Development Corp. · Jan 2005
SPACER G TEMPORARY HIP PROSTHESIS
K031841 · Exactech, Inc. · Jan 2004