Cleared Traditional

K010827 - COPELAND MB/HA RESURFACING HUMERAL HEADS

K010827 is the FDA 510(k) clearance for COPELAND MB/HA RESURFACING HUMERAL HEADS by Biomet Orthopedics, Inc.. It is a Class 2 Orthopedic device (product code HSD) cleared through the Traditional 510(k) pathway after a 178-day FDA review.

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
Combination Product No
PCCP Authorized No
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 51
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K010827.
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
K032264 · Howmedica Osteonics Corp. · Aug 2003
OXFORD MODULAR SHOULDER PROSTHESIS, 192.XXX CATALOGUE SERIES
K012377 · Corin USA · Mar 2002
COPELAND MB RESURFACING HUMERAL HEADS
K010657 · Biomet Manufacturing, Inc. · Sep 2001
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
K011942 · Tornier · Jul 2001
COPELAND RESURFACING HUMERAL HEADS
K010664 · Biomet Manufacturing, Inc. · Apr 2001
COPELAND RESURFACING HEADS
K003044 · Biomet, Inc. · Dec 2000