Cleared Traditional

DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM (K043505) - FDA 510(k) Clearance

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

K043505 · Biomet, Inc. · Orthopedic device
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Feb 2005
Decision
51d
Days
Class 2
Risk

K043505 is an FDA 510(k) clearance for the DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 9, 2005 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet, Inc. devices

Submission Details

510(k) Number K043505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2004
Decision Date February 09, 2005
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
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 42
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K043505.
BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION
K110791 · Zimmer, Inc. · Sep 2011
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
K110706 · Exactech, Inc. · May 2011
ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
K050761 · Zimmer, Inc. · Apr 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