Cleared Traditional

K042321 - MOSAIC NON-MODULAR PROXIMAL BODY AND EA...

K042321 is an FDA 510(k) clearance for MOSAIC NON-MODULAR PROXIMAL BODY AND EA..., manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code KWT cleared through the Traditional 510(k) pathway after a 155-day FDA review.

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

FDA 510(k) Submission Details - K042321

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
Combination Product No
PCCP Authorized No
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.

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 59
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K042321.
ANA0TOMICAL SHOULDER TM COMBINED SYSTEM
K103404 · Zimmer GmbH · Mar 2011
ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
K050761 · Zimmer, Inc. · Apr 2005
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
K043505 · Biomet, Inc. · Feb 2005
ZIMMER TRABECULAR METAL HUMERAL STEM
K041549 · Zimmer, Inc. · Sep 2004
INTERLOK BIO-MODULAR HUMERAL STEMS
K032507 · Biomet, Inc. · Sep 2003
BIO-MODULAR SHOULDER SYSTEM
K030710 · Biomet, Inc. · Jun 2003