Cleared Traditional

DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM (K033280) - FDA 510(k) Clearance

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

K033280 · Biomet, Inc. · Orthopedic device
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Dec 2003
Decision
70d
Days
Class 2
Risk

K033280 is an FDA 510(k) clearance for the DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM. Classified as Prosthesis, Elbow, Constrained, Cemented (product code JDC), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3150 - 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 K033280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2003
Decision Date December 19, 2003
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDC Prosthesis, Elbow, Constrained, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3150
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 - JDC Prosthesis, Elbow, Constrained, Cemented

All 21
Devices cleared under the same product code (JDC) and FDA review panel - the closest regulatory comparables to K033280.
POROUS COATED DISCOVERY ELBOW
K051975 · Biomet, Inc. · Sep 2005
LPS UPPER EXTREMITY
K042664 · Depuy, Inc. · Dec 2004
COONRAD/MORREY ELBOW CEMENT RESTRICTOR
K040389 · Zimmer, Inc. · May 2004
BIOMET'S MINIMALLY CONSTRAINED ELBOW
K003253 · Biomet, Inc. · Jan 2001
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
K001989 · Zimmer, Inc. · Jul 2000
MODIFIED SINGLE AXLE TOTAL ELBOW
K000683 · Biomet, Inc. · Jun 2000