Cleared Traditional

K042321 - MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042321 · Biomet Manufacturing Corp · Orthopedic device
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Jan 2005
Decision
155d
Days
Class 2
Risk

K042321 is an FDA 510(k) clearance for the MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on January 28, 2005 after a review of 155 days - an extended review cycle.

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 Biomet Manufacturing Corp devices

Submission Details

510(k) Number K042321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2004
Decision Date January 28, 2005
Days to Decision 155 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 122d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 70
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K042321.
Equinoxe® Humeral Reconstruction Prosthesis
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Tornier Humeral Reconstruction System Max (Tornier HRS Max)
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AGILON® XO Shoulder Replacement System
K241944 · Implantcast GmbH · Mar 2025
InSet Total Shoulder System
K241817 · Shoulder Innovations, Inc. · Feb 2025
AGILON® XO Shoulder Replacement System
K231657 · Implantcast GmbH · Feb 2024
Comprehensive Segmental Revision System(SRS)
K223631 · Biomet Orthopedics · Jul 2023