Cleared Traditional

COPELAND MB/HA RESURFACING HUMERAL HEADS (K010827) - FDA 510(k) Clearance

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

K010827 · Biomet Orthopedics, Inc. · Orthopedic device
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Sep 2001
Decision
178d
Days
Class 2
Risk

K010827 is an FDA 510(k) clearance for the COPELAND MB/HA RESURFACING HUMERAL HEADS. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Biomet Orthopedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 14, 2001 after a review of 178 days - an extended review 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: 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 Orthopedics, Inc. devices

Submission Details

510(k) Number K010827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2001
Decision Date September 14, 2001
Days to Decision 178 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
56d slower than avg
Panel avg: 122d · This submission: 178d
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 33
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K010827.
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
COPELAND RESURFACING HEADS
K003044 · Biomet, Inc. · Dec 2000
ISS OFFSET HEADS
K003428 · Biomet, Inc. · Nov 2000
SOLAR SHOULDER OFFSET HUMERAL HEAD
K001419 · Howmedica Osteonics Corp. · Jul 2000