Cleared Special

K030344 - MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K030344 · Smith & Nephew, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Mar 2003
Decision
29d
Days
Class 2
Risk

K030344 is an FDA 510(k) clearance for the MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS. Classified as Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (product code KWS), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on March 4, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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 K030344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2003
Decision Date March 04, 2003
Days to Decision 29 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
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 - KWS Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

All 189
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