Cleared Special

INTERLOK BIO-MODULAR HUMERAL STEMS (K032507) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K032507 · Biomet, Inc. · Orthopedic device
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Sep 2003
Decision
22d
Days
Class 2
Risk

K032507 is an FDA 510(k) clearance for the INTERLOK BIO-MODULAR HUMERAL STEMS. Classified as Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (product code KWT), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 5, 2003 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3650 - 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.

View all Biomet, Inc. devices

Submission Details

510(k) Number K032507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2003
Decision Date September 05, 2003
Days to Decision 22 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
100d faster than avg
Panel avg: 122d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3650
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 - KWT Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

All 42
Devices cleared under the same product code (KWT) and FDA review panel - the closest regulatory comparables to K032507.
ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
K050761 · Zimmer, Inc. · Apr 2005
DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM
K043505 · Biomet, Inc. · Feb 2005
ZIMMER TRABECULAR METAL HUMERAL STEM
K041549 · Zimmer, Inc. · Sep 2004
BIO-MODULAR SHOULDER SYSTEM
K030710 · Biomet, Inc. · Jun 2003
SHORT AND LONG SOFT TISSUE ATTACHMENT
K022079 · Biomet, Inc. · Sep 2002
BIOMET BI-POLAR SHOULDER SYSTEM
K002998 · Biomet, Inc. · Oct 2000