Cleared Special

K010664 - COPELAND RESURFACING HUMERAL HEADS

K010664 is an FDA 510(k) clearance for COPELAND RESURFACING HUMERAL HEADS, manufactured by Biomet Manufacturing, Inc.. The device is a Class 2 Orthopedic device with product code HSD cleared through the Special 510(k) pathway after a 30-day FDA review.

K010664 · Biomet Manufacturing, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
30d
Days
Class 2
Risk

K010664 is an FDA 510(k) clearance for the COPELAND RESURFACING HUMERAL HEADS. Classified as Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (product code HSD), Class II - Special Controls.

Submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 5, 2001 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K010664

510(k) Number K010664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2001
Decision Date April 05, 2001
Days to Decision 30 days
Submission Type Special
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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 70
Devices cleared under the same product code (HSD) and FDA review panel - the closest regulatory comparables to K010664.
COPELAND MB RESURFACING HUMERAL HEADS
K010657 · Biomet Manufacturing, Inc. · Sep 2001
COPELAND MB/HA RESURFACING HUMERAL HEADS
K010827 · Biomet Orthopedics, Inc. · Sep 2001
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
K011942 · Tornier · Jul 2001
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
K010664 · COPELAND RESURFACING HUMERAL HEADS
Download PDF FDA Summary Biomet Manufacturing,…