Cleared Traditional

COPELAND RESURFACING HEADS (K003044) - FDA 510(k) Clearance

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

K003044 · Biomet, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Dec 2000
Decision
75d
Days
Class 2
Risk

K003044 is an FDA 510(k) clearance for the COPELAND RESURFACING HEADS. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 13, 2000 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3690 - 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 K003044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2000
Decision Date December 13, 2000
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3690
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 - HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 32
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K003044.
DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS
K033516 · DePuy Orthopaedics, Inc. · Dec 2003
GLOBAL CAP RESURFACING REPLACEMENT SHOULDER
K031971 · DePuy Orthopaedics, Inc. · Sep 2003
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
K032264 · Howmedica Osteonics Corp. · Aug 2003
ISS OFFSET HEADS
K003428 · Biomet, Inc. · Nov 2000
SOLAR SHOULDER OFFSET HUMERAL HEAD
K001419 · Howmedica Osteonics Corp. · Jul 2000
KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY
K961260 · Biomet, Inc. · Apr 1997