Cleared Traditional

K010827 - COPELAND MB/HA RESURFACING HUMERAL HEADS

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

K010827 · Biomet Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K010827

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.

HSD Device Classification - Class 2, Special Controls

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 66
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