Cleared Traditional

K103404 - ANA0TOMICAL SHOULDER TM COMBINED SYSTEM

K103404 is an FDA 510(k) clearance for ANA0TOMICAL SHOULDER TM COMBINED SYSTEM, manufactured by Zimmer GmbH. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K103404 · Zimmer GmbH · Orthopedic device
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Mar 2011
Decision
116d
Days
Class 2
Risk

K103404 is an FDA 510(k) clearance for the ANA0TOMICAL SHOULDER TM COMBINED SYSTEM. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Zimmer GmbH (Warsaw, US). The FDA issued a Cleared decision on March 15, 2011 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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 Zimmer GmbH devices

FDA 510(k) Submission Details - K103404

510(k) Number K103404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2010
Decision Date March 15, 2011
Days to Decision 116 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
6d faster than avg
Panel avg: 122d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWT Device Classification - Class 2, Special Controls

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 66
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K103404.
COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS)
K111746 · Biomet, Inc. · Dec 2011
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
K110791 · Zimmer, Inc. · Sep 2011
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
K110706 · Exactech, Inc. · May 2011
NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM
K071147 · Nexa Orthopedics, Inc. · Jul 2007
ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
K050761 · Zimmer, Inc. · Apr 2005
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
K043505 · Biomet, Inc. · Feb 2005