Cleared Special

K030344 - MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS

K030344 is an FDA 510(k) clearance for MODULAR NEER 3 HUMERAL STEMS AND MODULA..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code KWS cleared through the Special 510(k) pathway after a 29-day FDA review.

K030344 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K030344

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

KWS Device Classification - Class 2, Special Controls

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 191
Devices cleared under the same product code (KWS) and FDA review panel - the closest regulatory comparables to K030344.
AEQUALIS SHOULDER FRACTURE SYSTEM
K032679 · Tornier · Dec 2003
MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION
K031449 · Implex Corp. · Sep 2003
AMATOMICAL SHOULDER WITH REMOVABLE HEAD
K030259 · Centerplus Orthopedics, Inc. · Apr 2003
ARTHREX UNIVERS FRACTURE PROSTHESIS
K020345 · Arthrex, Inc. · Sep 2002
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II
K012788 · Smith & Nephew, Inc. · Mar 2002
3D HUMERAL HEADS
K012378 · Smith & Nephew, Inc. · Dec 2001
K030344 · MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
Download PDF FDA Summary Smith & Nephew, Inc.